Safety, Tolerability, Efficacy and Pharmacokinetics of Im... | NCT03969901

ID	Type	Description	Link
MK-7655A-021	Other Identifier	MSD
2019-000338-20	EudraCT Number

Label	Type	Description	Intervention Names
IMI/REL	Experimental	Participants with cIAI or cUTI will receive imipenem/cilastatin/relebactam (IMI/REL) via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days) up to a maximum of 14 days. Participants with HABP/VABP will receive IMI/REL via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection will receive IMI/REL via IV infusion for 14 days. All oral switch medications will be chosen from a list of acceptable approved agents and will be administered per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.	Drug: IMI/REL Drug: Oral Switch
Active Control	Active Comparator	Participants with cIAI or cUTI will receive active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days) up to a maximum of 14 days. Participants with HABP/VABP will receive active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection will receive active control via IV infusion for 14 days. All active control and oral switch medications will be administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications will be chosen from a list of acceptable approved agents.	Drug: Active Control Drug: Oral Switch

Name	Type	Description	Arm Group Labels	Other Names
IMI/REL	Drug	Age-based dosing: 12 to <18 years, IMI 500 and REL 250 mg, IV infusion every 6 hours 6 to <12 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours 2 to <6 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours 3 months to <2 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours Birth to <3 months, IMI 15 and REL 7.5 mg/kg, IV infusion every 8 hours NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention.

Measure	Description	Time Frame
Percentage of Participants With One or More Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs are presented.	Up to 28 days
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study medication due to an AE are presented.	Up to 14 days

Measure	Description	Time Frame
Percentage of Participants With All-cause Mortality Through Day 28	For each participant, survival status was assessed at Day 28 post-randomization. The percentage of participants with all-cause mortality through Day 28 is presented.	Up to Day 28
Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria include but are not limited to:

Requires hospitalization and treatment with intravenous (IV) antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of the following primary infection types: Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI).
For Age Cohorts 4 and 5, participant is at least 37 weeks postmenstrual age at the time of signing the informed consent/assent.
If female, must not be pregnant or breastfeeding, and at least 1 of the following conditions must apply: must not be a woman of childbearing potential (WOCBP); OR, if a WOCBP, must agree to follow contraceptive guidance during the intervention period and for at least 24 hours after the last dose of study intervention.
Has sufficient intravascular access to receive study drug through an existing peripheral or central line.

Exclusion Criteria:

Exclusion Criteria include but are not limited to:

Is expected to survive less than 72 hours.
Has a concurrent infection that would interfere with evaluation of response to the study antibacterials (imipenem/cilastatin/relebactam (IMI/REL) or Active Control), including any of the following: endocarditis; osteomyelitis; meningitis; prosthetic joint infection; active pulmonary tuberculosis; disseminated fungal infection; concomitant infection at the time of randomization that requires non-study systemic antibacterial therapy in addition to IV study treatment or oral step-down therapy (medications with only gram-positive activity [e.g., vancomycin, linezolid] are allowed).
Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction.
Has a cUTI, with any of the following: complete obstruction of any portion of the urinary tract (i.e., requiring a permanent indwelling urinary catheter or instrumentation); documented reflux of ileal loop urinary diversion; suspected or confirmed perinephric or intrarenal abscess; suspected or confirmed prostatitis, urethritis, or epididymitis; trauma to pelvis/urinary tract; presence of indwelling urinary catheter which cannot be removed at study entry.
Has any of the following medical conditions at screening: history of a seizure disorder (requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years); cystic fibrosis; history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to IMI, or to any carbapenem, cephalosporin, penicillin, or other β-lactam agent, or to other β-lactamase inhibitors (e.g., tazobactam, sulbactam, clavulanic acid, avibactam).
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound study results, or interfere with the participant's participation for the full duration of the study.
If less than 3 months of age, has received more than 72 hours of empiric antibacterial treatment for suspected meningitis prior to initiation of IV study intervention.
For all Age Cohorts, provided all other eligibility criteria are met, the following participants may be enrolled:
- A participant failing prior antibiotic therapy for a current episode of cUTI or HABP/VABP who: Has received the prior antibacterial treatment for at least 48 hours; Has persistent clinical or radiographic findings clearly indicating ongoing infection; Fulfills other laboratory or microbiology criteria for enrollment
- A participant failing prior antibiotic therapy for a current episode of cIAI who: Has received the prior antibacterial treatment for at least 48 hours; Has persistent clinical or radiographic findings clearly indicating ongoing infection; Fulfills other laboratory or microbiology criteria for enrollment; Has planned operative intervention no more than 24 hours after first dose of study treatment; Has not received any further nonstudy antibiotics postoperatively
If 3 months of age or older, or <3 months of age without suspected meningitis, has received potentially therapeutic antibacterial therapy (e.g., with gram-negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study intervention.
Is anticipated to be treated with any of the following medications: valproic acid or divalproex sodium (or has used valproic acid or divalproex sodium in the 2 weeks prior to screening) through 24 hours after completion of the final dose of IV study intervention for participants who receive IMI/REL or carbapenem; concomitant IV, oral, or inhaled antimicrobial agents with gram-negative activity, in addition to those designated in the study intervention groups, during the course of all (IV/oral) study intervention; planned receipt of suppressive/prophylactic antibiotics with gram-negative activity after completion of study intervention.
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to screening.
Has enrolled previously in the current study and been discontinued or has received REL for any other reason.
Has an estimated creatinine clearance (based on the Cockcroft-Gault equation, for participants ≥12 years of age or estimated glomerular filtration rate (eGFR), based on the modified Schwartz equation, for participants <12 years of age below that specified for the appropriate age range; or requires peritoneal dialysis, hemodialysis, or hemofiltration.
Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × upper limit of normal (ULN) at the time of screening. NOTE: Patients with acute hepatic failure or acute decompensation of chronic hepatic failure should also be excluded.
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner University Medical Center ( Site 0356)		Tucson	Arizona	85724	United States
Miller Children's & Women's Hospital ( Site 0349)

PubMed Identifier	Type	Citation	Retractions
42400209	Derived	Bradley JS, Norice CT, Roilides E, Shevelev A, Jurkiewicz B, Piedrahita JA, Macias-Parra M, Monroy Colin VA, Dalgic N, Koseoglu S, Masih I, Nair P, Young K, Hilbert DW, Nieddu GT, Patel M, Huntington JA, Paschke A, Bruno CJ. Phase 2/3, Open-label, Randomized, Active-controlled Clinical Trial Evaluating the Safety and Efficacy of Imipenem/Cilastatin/Relebactam in Pediatric Patients From Birth to Less Than 18 Years With Gram-negative Bacterial Infections. Pediatr Infect Dis J. 2026 Jul 7. doi: 10.1097/INF.0000000000005323. Online ahead of print.

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 20, 2023

Arm/Group Information

ID	Title	Description
BG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
BG001	Active Control Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
BG002	IMI/REL Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
BG003	Active Control Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
BG004	IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
BG005	Active Control Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
BG006	IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
BG007	Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
BG008	IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
BG009	Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
BG010	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With One or More Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs are presented.

All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

Percentage of Participants

Up to 28 days

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG001	Active Control Cohort 1: Adolescents: (12 to <18 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
OG002	IMI/REL Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG003	Active Control Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
OG004	IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG005	Active Control Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
OG006	IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG007	Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.
OG008	IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG009	Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.

Units	Counts
Participants	OG00010 OG0012 OG00231 OG003

Title

Denominators

Categories

Title	Measurements
	OG00060.0 OG00150.0 OG00264.5 OG003

Primary

Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)

All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

Percentage of Participants

Up to 14 days

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With All-cause Mortality Through Day 28

For each participant, survival status was assessed at Day 28 post-randomization. The percentage of participants with all-cause mortality through Day 28 is presented.

The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

Percentage of Participants

Up to Day 28

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG001	Active Control Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)

A favorable clinical response at EOT requires an assessment of "cure" or "improved". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Improved is defined as the majority of preintervention signs and symptoms of the index infection have improved or resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required. The percentage of participants with a favorable clinical response at EOT is presented.

The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 5 up to Day 14

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU)

A favorable clinical response at EFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at EFU is presented.

The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 12 up to Day 28

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)

A favorable clinical response at LFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at LFU is presented.

The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline and Day 19 up to Day 42

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)

A favorable microbial response is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EOT visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EOT visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EOT visit shows eradication of the uropathogen (reduced to <103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EOT is presented.

For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 5 up to Day 14

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)

A favorable microbiological response at EFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EFU visit shows eradication of the uropathogen (reduced to <103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EFU is presented.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 12 up to Day 28

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)

A favorable microbiological response at LFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the LFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the LFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the LFU visit shows eradication of the uropathogen (reduced to <103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at LFU is presented.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 19 up to Day 42

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL

AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Blood samples were collected to determine the AUC0-24 of imipenem.

The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM*hr

On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents: (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Relebactam Following Administration of IMI/REL

AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Blood samples were collected to determine the AUC0-24 of relebactam.

The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM*hr

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Secondary

Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL

Ceoi is the concentration of the drug at the end of infusion. Blood samples for analysis were collected within 10 minutes of the end of infusion to determine the Ceoi of imipenem.

The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM

At the end of the first infusion on Day 1.

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG001	IMI/REL Age Cohort 2: Older Children (6 to <12 Years)

Secondary

Concentration at End of Infusion (Ceoi) of Relebactam Following Administration of IMI/REL

Ceoi is the concentration of the drug at the end of infusion. Blood samples for analysis were collected within 10 minutes of the end of infusion to determine the Ceoi of relebactam.

The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM

At the end of the first infusion on Day 1.

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.
OG001	IMI/REL Age Cohort 2: Older Children (6 to <12 Years)

Secondary

Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T>MIC of Imipenem) Following Administration of IMI/REL

Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T>MIC) is defined as the cumulative percentage the drug concentration exceeds the MIC at steady state pharmacokinetic conditions. Blood samples were collected to determine %T>MIC of imipenem. %T>MIC is calculated using baseline microbiological response values.

The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample for %T>MIC.

Posted

Mean

Standard Deviation

Percentage of time

ID	Title	Description
OG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IMI/REL Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI and complicated urinary tract infection cUTI received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 500 mg/250 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.	10	0	10	6	10
EG001	Active Control Age Cohort 1: Adolescents (12 to <18 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.	2	0	2	1	2
EG002	IMI/REL Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.	31	6	31	17	31
EG003	Active Control Age Cohort 2: Older Children (6 to <12 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.	11	1	11	3	11
EG004	IMI/REL Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.	22	0	21	13	21
EG005	Active Control Age Cohort 3: Younger Children (2 to <6 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.	8	0	8	5	8
EG006	IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 6 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.	15	4	15	12	15
EG007	Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.	5	1	4	2	4
EG008	IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI and cUTI received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for a minimum of 5 days with an option of investigator's choice of locally sourced oral switch medication after a minimum of 3 days of IV therapy alone. Participants with HABP/VABP received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 7 days up to 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received IMI/REL fixed-dose combination of 15 mg/7.5 mg via IV infusion every 8 hours for 14 days. All oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All oral switch medications were chosen from a list of acceptable approved agents.	8	0	8	2	8
EG009	Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months)	Participants with cIAI or cUTI received investigator's choice of locally sourced active control via IV infusion for a minimum of 5 days (with optional investigator's choice of locally sourced oral switch medication after 3 days of IV therapy alone) up to a maximum of 14 days. Participants with HABP/VABP received investigator's choice of locally sourced active control via IV infusion for a minimum of 7 days up to a maximum of 14 days. Participants with bacteremia or Pseudomonas aeruginosa infection received investigator's choice of locally sourced active control via IV infusion for 14 days. All active control and oral switch medications were administered per authorized PI, SPC, or international treatment guidelines. All active control and oral switch medications were chosen from a list of acceptable approved agents.	3	1	3	1	3

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG0030 events0 affected11 at risk EG0041 events1 affected21 at risk EG0050 events0 affected8 at risk EG0061 events1 affected15 at risk EG0070 events0 affected4 at risk EG0080 events0 affected8 at risk EG0090 events0 affected3 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected31 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0024 events4 affected31 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0024 events4 affected31 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected2 at risk EG00215 events5 affected31 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected2 at risk EG0025 events5 affected31 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Infusion site extravasation	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003
Infusion site phlebitis	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected2 at risk EG0020 events0 affected31 at risk EG003
Medical device site dermatitis	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Oedema	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected31 at risk EG003
Thirst	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Vascular device occlusion	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Device related infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Otitis media	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Pyuria	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Rhinitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0023 events3 affected31 at risk EG003
Creatinine urine decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Urine uric acid increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Urobilinogen urine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
pH urine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected31 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Urethral fistula	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Food poisoning	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG0030 events0 affected11 at risk EG0040 events0 affected21 at risk EG0050 events0 affected8 at risk EG0060 events0 affected15 at risk EG0070 events0 affected4 at risk EG0080 events0 affected8 at risk EG0090 events0 affected3 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0022 events2 affected31 at risk EG003
Short-bowel syndrome	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Drug intolerance	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Neonatal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0020 events0 affected31 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected2 at risk EG0021 events1 affected31 at risk EG003