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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002120-32 | EudraCT Number |
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The primary objectives of this study are:
This is a multicenter, single-arm, open-label, single- and multiple-dose study to assess the safety, tolerability, and PK of cefiderocol in hospitalized paediatric participants.
The single-dose phase will include 4 separate cohorts of participants, grouped according to age range:
The multiple-dose phase will include 3 cohorts according to age range (Cohorts 2, 3, and 4) and will begin after safety and PK data from 6 participants in the corresponding single-dose cohort have been assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Phase: Cefiderocol | Experimental | Participants will receive a single dose of cefiderocol administered intravenously (IV) on Day 1, in addition to standard of care. Participants weighing less than 34 kilograms (kg) will receive 60 milligrams (mg)/kg of cefiderocol and participants ≥34 kg will receive 2000 mg. |
|
| Multiple Dose Phase: Cefiderocol | Experimental | Participants will receive cefiderocol administered via IV every 8 hours on Day 1 and continuing for 5 to 14 days in addition to standard of care. Participants weighing less than 34 kg will receive 60 mg/kg of cefiderocol and participants ≥34 kg will receive 2000 mg. Dosage may be adjusted based on renal function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefiderocol | Drug | Administered intravenously over 3 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Day 1 up to Day 28 |
| Multiple-Dose Phase: Number of Participants With TEAEs | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Day 1 up to Day 42 |
| Single Dose Phase: Maximum Observed Plasma Concentration (Cmax) of Cefiderocol | Up to 8 hours postdose | |
| Single Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity (AUCinf) of Cefiderocol | Up to 8 hours postdose | |
| Single Dose Phase: Apparent Terminal Elimination Half-life (t1/2) of Cefiderocol |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator | The clinical outcomes were clinical cure, clinical failure, and indeterminate. Clinical Cure: Resolution or substantial improvement of baseline signs and symptoms. Participants with bacteremia must have had eradication of bacteremia caused by the Gram-negative pathogen. Clinical Failure: No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms, reappearance of signs and/or symptoms; development of new signs and/or symptoms requiring antibiotic therapy other than, or in addition to, study treatment therapy; or death due to pneumonia/complicated intra-abdominal infection (cIAI) or complicated urinary tract infections (cUTI) or bloodstream infection (BSI)/sepsis. Indeterminate: Lost to follow-up such that a determination of clinical cure/failure could not be made. |
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Inclusion Criteria:
Exclusion Criteria:
Participant has a documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment).
Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen.
Participant has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
Participant has cystic fibrosis.
Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 60 milliliter (mL) per minute (min)/1.73 ^2² at Screening.
Multiple-dose phase: Participant has an eGFR (based on Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 15 mL/min/1.73 ^2² at Screening.
Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
Participant has experienced shock in the prior month or is in shock at the time of Screening.
Participant has severe neutropenia or is severely immunocompromised.
Participant has multiorgan failure.
Participant has a life expectancy of < 30 days due to severity of a concurrent illness.
Participant is a female who has a positive pregnancy test at Screening.
Participant is a female who is breastfeeding.
Participant has received any other investigational medicinal product (IMP) within 30 days.
Participant has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data, including acute trauma to the pelvis or urinary tract.
Participant is receiving vasopressor therapy at Screening.
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | 1200 | Belgium | |||
| Cliniques Universitaires Saint-Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39230271 | Derived | Bradley JS, Orchiston E, Portsmouth S, Ariyasu M, Baba T, Katsube T, Makinde O. Pharmacokinetics, Safety and Tolerability of Single-dose or Multiple-dose Cefiderocol in Hospitalized Pediatric Patients Three Months to Less Than Eighteen Years Old With Infections Treated With Standard-of-care Antibiotics in the PEDI-CEFI Phase 2 Study. Pediatr Infect Dis J. 2025 Feb 1;44(2):136-142. doi: 10.1097/INF.0000000000004529. Epub 2024 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Dose Phase: Cohort 1 (12 to <18 Years) | Participants received a single dose of cefiderocol administered as an intravenous (IV) infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| FG001 | Single-Dose Phase: Cohort 2 (6 to <12 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Single-Dose Phase (Day 1) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Jan 21, 2026 |
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| Standard of Care | Drug | Standard of care antibiotics will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards. |
|
| Up to 8 hours postdose |
| Multiple Dose Phase: Cmax of Cefiderocol | Up to 8 hours postdose |
| Multiple Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to the Last Measurable Concentration (AUC0-t) of Cefiderocol | Up to 8 hours postdose |
| Multiple Dose Phase: t1/2 of Cefiderocol | Up to 8 hours postdose |
| End of treatment (EOT; up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and end of study (EOS; 28 days after last dose [up to Day 42]) |
| Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator | Microbiological outcomes were eradication, persistence, and indeterminate. For hospital-acquired pneumonia (HAP)/ventilator-acquired pneumonia (VAP)/cIAI and BSI/sepsis- Eradication: Absence of baseline Gram-negative pathogen from an appropriate clinical specimen; Persistence: Continued presence of baseline Gram-negative pathogen from an appropriate clinical specimen; Indeterminate: No culture obtained from an appropriate clinical specimen or additional antibiotic therapy for the treatment of current infection including missed sampling. For cUTI- Eradication: A urine culture showed baseline Gram-negative uropathogen found at entry at ≥10^5 colony forming units (CFU)/milliliters (mL) was reduced to <10^3 CFU/mL; Persistence: A urine culture showed that the baseline Gram-negative uropathogen found at entry at ≥10^5 CFU/mL remained at ≥10^3 CFU/mL; Indeterminate: No urine culture obtained or additional antibiotic therapy for the treatment of current infection including missed sampling. | EOT (up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and EOS (28 days after last dose [up to Day 42]) |
| Brussels |
| Belgium |
| Tallinn Childrens Hospital | Tallinn | Estonia |
| Tartu Ulikooli Kliinikum - Anestesioloogia ja Intensiivravi Kliinik | Tartu | Estonia |
| JSC "Medical Corporation Evex" " M. Iashvili Batumi Maternal and Child Central Hospital" | Batumi | Georgia |
| JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital | Tbilisi | Georgia |
| Ltd Unimedi Kakheti Childrens New Clinic | Tbilisi | Georgia |
| Heim Pl Orszgos Gyermekgygyszati Intzet | Pilisborosjenő | Hungary |
| Szegedi Tudomnyegyetem | Szegedi Tudomnyegyetem | Hungary |
| Daugavpils regional Hospital | Daugavpils | Latvia |
| Bernu Kliniska Universitates Slimnica Childrens Hospital - Tornakalna | Riga | Latvia |
| St. Petersburg State Pediatric Medical University | Saint Petersburg | Russia |
| Smolensk State Medical University | Smolensk | Russia |
| Hospital Germans Trias i Pujol | Barcelona | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | Spain |
| King Chulalongkorn Memorial Hospital, Chulalongkorn University | Bangkok | Thailand |
| Siriraj Hospital | Bangkok Noi | Thailand |
| PHPT-Chiangrai PrachanuKroh Hospital | Chiang Mai | Thailand |
| Khon Kaen University (KKU) - Faculty of Medicine-Srinagarind Hospital | Khon Kaen | Thailand |
| Dnipropetrovsk Regional Children Clinical Hospital | Kharkiv | Ukraine |
| Regional Children Clinical Hospital | Kharkiv | Ukraine |
| National Childrens Specialized Hospital OHMATDYT of the Ministry of Health of Ukraine | Kiev | Ukraine |
| Higher State Educational Institute of Ukraine Ukrainian Medical Stamatological Academy | Poltava | Ukraine |
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| FG002 | Single-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| FG003 | Single-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| FG004 | Multiple-Dose Phase: Cohort 2 (6 to <12 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| FG005 | Multiple-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| FG006 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Multiple-Dose Phase (Up to 14 Days) |
|
|
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-Dose Phase: Cohort 1 (12 to <18 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| BG001 | Single-Dose Phase: Cohort 2 (6 to <12 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| BG002 | Single-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| BG003 | Single-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| BG004 | Multiple-Dose Phase: Cohort 2 (6 to <12 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| BG005 | Multiple-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| BG006 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Single-Dose Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Safety population included all enrolled participants who received at least 1 dose of cefiderocol. | Posted | Count of Participants | Participants | Day 1 up to Day 28 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Multiple-Dose Phase: Number of Participants With TEAEs | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | Safety population included all enrolled participants who received at least 1 dose of cefiderocol. | Posted | Count of Participants | Participants | Day 1 up to Day 42 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator | The clinical outcomes were clinical cure, clinical failure, and indeterminate. Clinical Cure: Resolution or substantial improvement of baseline signs and symptoms. Participants with bacteremia must have had eradication of bacteremia caused by the Gram-negative pathogen. Clinical Failure: No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms, reappearance of signs and/or symptoms; development of new signs and/or symptoms requiring antibiotic therapy other than, or in addition to, study treatment therapy; or death due to pneumonia/complicated intra-abdominal infection (cIAI) or complicated urinary tract infections (cUTI) or bloodstream infection (BSI)/sepsis. Indeterminate: Lost to follow-up such that a determination of clinical cure/failure could not be made. | The Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of cefiderocol. | Posted | Count of Participants | Participants | End of treatment (EOT; up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and end of study (EOS; 28 days after last dose [up to Day 42]) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator | Microbiological outcomes were eradication, persistence, and indeterminate. For hospital-acquired pneumonia (HAP)/ventilator-acquired pneumonia (VAP)/cIAI and BSI/sepsis- Eradication: Absence of baseline Gram-negative pathogen from an appropriate clinical specimen; Persistence: Continued presence of baseline Gram-negative pathogen from an appropriate clinical specimen; Indeterminate: No culture obtained from an appropriate clinical specimen or additional antibiotic therapy for the treatment of current infection including missed sampling. For cUTI- Eradication: A urine culture showed baseline Gram-negative uropathogen found at entry at ≥10^5 colony forming units (CFU)/milliliters (mL) was reduced to <10^3 CFU/mL; Persistence: A urine culture showed that the baseline Gram-negative uropathogen found at entry at ≥10^5 CFU/mL remained at ≥10^3 CFU/mL; Indeterminate: No urine culture obtained or additional antibiotic therapy for the treatment of current infection including missed sampling. | The Microbiological Intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of cefiderocol and who had a baseline Gram-negative pathogen from any specimen from a baseline infection site. | Posted | Count of Participants | Participants | EOT (up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and EOS (28 days after last dose [up to Day 42]) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Single Dose Phase: Maximum Observed Plasma Concentration (Cmax) of Cefiderocol | The Pharmacokinetic (PK) Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms (µg)/milliliter (mL) | Up to 8 hours postdose |
| |||||||||||||||||||||||||||||||||||||
| Primary | Single Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity (AUCinf) of Cefiderocol | The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*hours/mL | Up to 8 hours postdose |
| |||||||||||||||||||||||||||||||||||||
| Primary | Single Dose Phase: Apparent Terminal Elimination Half-life (t1/2) of Cefiderocol | The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Up to 8 hours postdose |
| |||||||||||||||||||||||||||||||||||||
| Primary | Multiple Dose Phase: Cmax of Cefiderocol | The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Up to 8 hours postdose |
| |||||||||||||||||||||||||||||||||||||
| Primary | Multiple Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to the Last Measurable Concentration (AUC0-t) of Cefiderocol | The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*hours/mL | Up to 8 hours postdose |
| |||||||||||||||||||||||||||||||||||||
| Primary | Multiple Dose Phase: t1/2 of Cefiderocol | The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Up to 8 hours postdose |
|
Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-Dose Phase: Cohort 1 (12 to <18 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Single-Dose Phase: Cohort 2 (6 to <12 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Single-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Single-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Multiple-Dose Phase: Cohort 2 (6 to <12 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG005 | Multiple-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG006 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function. | 0 | 6 | 1 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Device connection issue | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
The sponsor can embargo results from a PIs center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 45 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi Inc. | 800-849-9707 | shionogiclintrials-admin@shionogi.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Jan 21, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D018805 | Sepsis |
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003428 | Cross Infection |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097602 | Cefiderocol |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| OG002 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
| OG001 | Multiple-Dose Phase: Cohort 3 (2 to <6 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
| OG002 | Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
| OG003 |
| Single-Dose Phase: Cohort 4 (3 Months to <2 Years) |
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
| OG003 | Single-Dose Phase: Cohort 4 (3 Months to <2 Years) | Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
| Single-Dose Phase: Cohort 4 (3 Months to <2 Years) |
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only. |
|
|
|
|
|
|
|
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|
| Indeterminate |
|