Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazoba... | NCT02493764

ID	Type	Description
2015-000246-34	EudraCT Number
163240	Registry Identifier	JAPIC-CTI
MK-7655A-014	Other Identifier	Merck Protocol Number

Label	Type	Description	Intervention Names
IMI/REL	Experimental	Imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.	Drug: Imipenem Drug: Relebactam Drug: Cilastatin Drug: Linezolid
PIP/TAZ	Active Comparator	Piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.	Drug: Piperacillin Drug: Tazobactam Drug: Linezolid

Name	Type	Description	Arm Group Labels	Other Names
Imipenem	Drug	Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days	IMI/REL

Measure	Description	Time Frame
Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population	The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.	Up to 28 days

Measure	Description	Time Frame
Percentage of Participants in the MITT Population With a Favorable Clinical Response (FCR) at Early Follow-up (EFU) Visit	The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture
Has an infection known or thought to be caused by microorganisms susceptible to the IV study therapy
Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing, long term storage, and other future testing
Is not of reproductive potential; or if of reproductive potential agrees to avoid impregnating a partner or avoid becoming pregnant, by practicing abstinence or using acceptable contraception

Exclusion Criteria:

Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
Has HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
Has a carcinoid tumor or carcinoid syndrome
Has active immunosuppression defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency
Is expected to survive for less than 72 hours
Has a concurrent condition or infection that would preclude evaluation of therapeutic response
Has received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours continuously, during the previous 72 hours
Has a history of serious allergy, hypersensitivity or a serious reaction to any penicillin or beta-lactamase inhibitors
Female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed
Has a history of seizure disorder requiring ongoing prior treatment with anti-convulsive therapy within the last 3 years
Anticipates treatment with the following: valproic acid or divalproex sodium, serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor antagonists, meperidine, buspirone, concomitant systemic antibacterial agents, antifungal or antiviral therapy for the index infection of HABP/VABP
Is currently undergoing hemodialysis or peritoneal dialysis
Is currently participating in, has participated in during the previous 30 days, or anticipates to participate in any other clinical study involving the administration of experimental medication
Has previously participated in this study

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

PubMed Identifier	Type	Citation	Retractions
41586496	Derived	Patel M, Nieddu G, DeRyke CA, Young K, Chen LF, Paschke A, Rizk ML, Gheyas F. Imipenem/cilastatin/relebactam dosing regimen justification using exposure-efficacy analyses in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia in the RESTORE-IMI 2 phase 3 study. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0131325. doi: 10.1128/aac.01313-25. Epub 2026 Jan 26.
37383243

ID	Title	Description
FG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a fixed dose combination (FDC) administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

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	Sep 6, 2018

ID	Title	Description
BG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
BG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000268 BG001269 BG002537

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 All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population

The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.

The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline lower respiratory tract (LRT) specimen.

Posted

Number

Percentage of participants

Up to 28 days

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Units	Counts
Participants	OG000264 OG001267

Title

Denominators

Categories

Title	Measurements
	OG00015.9 OG00121.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Adjusted difference in all-cause mortality	t-test, 1 sided	A one-sided alpha level of 0.025 was used to declare significance.	<0.001		Adjusted difference in ACM	-5.3			2-Sided	95	-11.9	1.2			Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.		Non-Inferiority	Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was < 10 percentage points.

Secondary

Percentage of Participants in the MITT Population With a Favorable Clinical Response (FCR) at Early Follow-up (EFU) Visit

The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).

The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline LRT specimen.

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to 30 days)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants With ≥1 Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

All participants who received ≥1 dose of study therapy are included.

Posted

Number

Percentage of participants

Up to 30 days

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants Discontinuing Study Therapy Due to an AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

All participants who received ≥1 dose of study therapy are included.

Posted

Number

Percentage of participants

Up to 14 days

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants With ACM in the Microbiological Modified Intention-to-treat (mMITT) Population

The percentage of participants in the mMITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.

The mMITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci only on baseline Gram stain and who have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity.

Posted

Number

Percentage of participants

Up to 28 days

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants With ACM at EFU in the MITT Population

The percentage of participants in the MITT population with mortality due to any cause from randomization through EFU was determined for each arm.

The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline specimen.

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to 30 days)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants With ACM at EFU in the mMITT Population

The percentage of participants in the mMITT population with mortality due to any cause from randomization through EFU was determined for each arm.

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to 30 days)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the Clinically Evaluable (CE) Population With a FCR at On-therapy Visit 1 (OTX1) [Day 3]

The percentage of participants with a FCR at OTX1 was determined for each arm. Favorable clinical response at OTX1 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).

The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have Day 3 clinical response data.

Posted

Number

Percentage of participants

Day 3 (OTX1)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the CE Population With a FCR at OTX2 (Day 6)

The percentage of participants with a FCR at OTX2 was determined for each arm. Favorable clinical response at OTX2 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).

Posted

Number

Percentage of participants

Day 6 (OTX2)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the CE Population With a FCR at OTX3 (Day 10)

The percentage of participants with a FCR at OTX3 was determined for each arm. Favorable clinical response at OTX3 was defined as "improved" (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"]).

Posted

Number

Percentage of participants

Day 10 (OTX3)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the CE Population With a FCR at EOT Visit

The percentage of participants with a FCR at EOT was determined for each arm. Favorable clinical response at EOT was defined as either "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required) or "improved" (the majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to "pre-infection status"] and no additional antibiotics are required).

Posted

Number

Percentage of participants

From Day 7 to Day 14

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the CE Population With a FCR at Day 28

The percentage of participants with a FCR at Day 28 was determined for each arm. Favorable clinical response at Day 28 was defined as either "sustained cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] with no evidence of resurgence and no additional antibiotics are required) or "cure" (all pre-therapy signs and symptoms of the index infection have resolved [or returned to "pre-infection status"] and no additional antibiotics are required).

Posted

Number

Percentage of participants

Day 28

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the CE Population With a FCR at EFU Visit

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to Day 30)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ

Secondary

Percentage of Participants in the MITT Population With a FCR at OTX1 (Day 3)

The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 3 data.

Posted

Number

Percentage of participants

Day 3 (OTX1)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the MITT Population With a FCR at OTX2 (Day 6)

The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 6 data.

Posted

Number

Percentage of participants

Day 6 (OTX2)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the MITT Population With a FCR at OTX3 (Day 10)

The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 10 data.

Posted

Number

Percentage of participants

Day 10 (OTX3)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the MITT Population With a FCR at EOT

The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have EOT data.

Posted

Number

Percentage of participants

From Day 7 to Day 14

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the MITT Population With a FCR at Day 28

The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 28 data.

Posted

Number

Percentage of participants

Day 28

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the mMITT Population With a Favorable Microbiological Response (FMR) at End of Treatment (EOT) Visit

The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).

The mMITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci only on baseline Gram stain, have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity, and have EOT data.

Posted

Number

Percentage of participants

From Day 7 to Day 14

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the mMITT Population With a FMR at EFU Visit

The percentage of participants with a FMR at EFU was determined for each arm. Favorable microbiological response at EOT was defined as either "eradication" (a lower respiratory tract culture taken at EFU showing eradication of baseline pathogen) or "presumed eradication" (no specimen collected because the participant deemed clinically cured or improved).

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to Day 30)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the Microbiologically Evaluable (ME) Population With a FMR at EOT Visit

The ME population is all randomized participants with ≥1 dose of study therapy; not only gram-positive cocci on baseline Gram stain; IMI/REL-sensitive baseline pathogen as cause of HABP/VABP; met entry criteria; no protocol deviations; received minimum duration of IV therapy; have microbiological EOT data and LRT culture available.

Posted

Number

Percentage of participants

From Day 7 to Day 14

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Secondary

Percentage of Participants in the ME Population With a FMR at EFU Visit

Posted

Number

Percentage of participants

Up to 16 days after end of therapy (up to Day 30)

ID	Title	Description
OG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
OG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Splenic lesion	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0012 events2 affected269 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG00012 events10 affected266 at risk EG0019 events7 affected269 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0012 events2 affected269 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0012 events2 affected269 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0012 events2 affected269 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected266 at risk EG0014 events4 affected269 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Intestinal ulcer	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Brain death	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Death	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0016 events6 affected269 at risk
Vascular stent thrombosis	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0012 events2 affected269 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Brain abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Carbuncle	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Endocarditis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Fungaemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Intervertebral discitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Lung abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Meningitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Neurological infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Peritonitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 events6 affected266 at risk EG0013 events3 affected269 at risk
Pneumonia acinetobacter	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Post procedural sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected266 at risk EG0013 events3 affected269 at risk
Septic shock	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0007 events7 affected266 at risk EG0014 events4 affected269 at risk
Skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Spinal cord infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Tracheitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Implant tissue necrosis	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Spinal shock	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0012 events1 affected269 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected266 at risk EG0011 events1 affected269 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0011 events1 affected269 at risk
Hepatic enzyme increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0012 events2 affected269 at risk
Basilar artery thrombosis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Brain dislocation syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0013 events3 affected269 at risk
Brain oedema	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0013 events3 affected269 at risk
Cerebral infarction	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Coma	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0013 events3 affected269 at risk
Hydrocephalus	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0011 events1 affected269 at risk
Lethargy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0012 events1 affected269 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0018 events8 affected269 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0011 events1 affected269 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0011 events1 affected269 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0010 events0 affected269 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Pleural fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected266 at risk EG0010 events0 affected269 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0012 events2 affected269 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected266 at risk EG0010 events0 affected269 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0012 events2 affected269 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected266 at risk EG0013 events3 affected269 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Circulatory collapse	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected266 at risk EG0012 events2 affected269 at risk
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected266 at risk EG0010 events0 affected269 at risk
Haemodynamic instability	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected266 at risk EG0011 events1 affected269 at risk

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D013845	Thienamycins
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003521	Cyclopropanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D005229	Fatty Acids, Monounsaturated
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D013457	Sulfur Compounds
D010397	Penicillanic Acid
D013450	Sulfones
D000081	Acetamides
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D023303	Oxazolidinones
D010080	Oxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IMI/REL	Participants received imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.	44	266	71	266	98	266
EG001	PIP/TAZ	Participants received piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until MRSA was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.	58	269	86	269	105	269

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00030 events28 affected266 at risk EG00128 events27 affected269 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00022 events21 affected266 at risk EG00132 events29 affected269 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00019 events11 affected266 at risk EG00129 events20 affected269 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00025 events23 affected266 at risk EG00118 events18 affected269 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00031 events29 affected266 at risk EG00119 events19 affected269 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00019 events18 affected266 at risk EG00125 events24 affected269 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00015 events14 affected266 at risk EG0013 events3 affected269 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00011 events11 affected266 at risk EG00117 events14 affected269 at risk

ID	Term
D015378	Imipenem
C568736	relebactam
D015377	Cilastatin
D010878	Piperacillin
D000078142	Tazobactam
D000069349	Linezolid