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COMPLETEDPHASE2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

NCT04215991•Shionogi

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).

Detailed Description

This study consists of a nonrandomized single-dose phase in children aged 3 months to less than 12 years with suspected or confirmed aerobic Gram-negative bacterial infections and a randomized multiple-dose, active-comparator standard of care (SOC) phase in children aged 3 months to less than 18 years with cUTI, HABP, or VABP to assess the PK, safety, and tolerability of cefiderocol in hospitalized participants requiring systemic antibiotics for an expected 5 to 14 days.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant's parent(s) or legally authorized representative(s) (LAR) provides written informed consent in accordance with regional- and country-specific laws and regulations
•2. Participant provides written informed assent, when feasible (age of assent to be determined by institutional review board/independent ethics committee \[IRBs/IECs\] or be consistent with local legal requirements)
•3. Hospitalized participant is 3 months to \< 18 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Hospitalized participant is 3 months to \< 12 years of age at the time written informed consent/assent is obtained for the single-dose phase.
•4. Single-dose phase: Participant has a suspected or confirmed infection type (including but not limited to cUTI, complicated intra-abdominal infections \[cIAI\], pneumonia, HABP/VABP, and sepsis or bloodstream infections \[BSI\]) that requires hospitalization for treatment with IV antibiotics.
•Multiple-dose phase: Participant has a suspected or confirmed cUTI, HABP, or VABP that requires hospitalization for treatment with IV antibiotics
•5. If participant is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, participant agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use a highly effective method of contraception (including contraceptive implant, injectable contraceptive, combination oral contraceptive, or an intrauterine \[IUD\] contraceptive device) from Screening up to 28 days after administration of the last dose of cefiderocol.

Exclusion Criteria

•1. 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.)
•2. Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen.
•3. Participant has a suspected or confirmed central nervous system (CNS) infection (for example, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
•4. Participant has cystic fibrosis.
•5. Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on the 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)/ minute (min)/1.73 square meters (m\^2)² at Screening .
•Multiple-dose phase: Participant has an eGFR (based on the 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 m² at Screening.
•6. Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
•7. Participant has experienced shock in the prior month or is in shock at the time of Screening.
•8. Participant has severe neutropenia or is severely immunocompromised.
•9. Participant has multiorgan failure .
+6 more criteria

Locations (25)

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street

South Brisbane, Queensland, Australia

JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital

Tbilisi, Georgia

Ltd Unimedi Kakheti Childrens New Clinic

Tbilisi, Georgia

Heraklion University General Hospital

Heraklion, Crete, Greece

University General Hospital of Larissa

Larissa, Thessaly, Greece

University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA

Chaïdári, Greece

Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49

Thessaloniki, Greece

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, Greece

Key Dates

Start Date

February 19, 2020

Primary Completion Date

September 17, 2024

Completion Date

September 17, 2024

Last Updated

May 25, 2025

Enrollment

ACTUAL participants

Conditions

Gram-negative Bacterial InfectionsHospital Acquired Bacterial Pneumonia (HABP)Complicated Urinary Tract Infection (cUTI)Ventilator Associated Bacterial Pneumonia (VABP)

Interventions

Cefiderocol

DRUG

Standard of Care

DRUG

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

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Gram Negative PneumoniaGram-Negative Bacterial Infections+1 more

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COMPLETEDPHASE2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

NCT06086626

Gram-Negative Bacterial Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

Inclusion Criteria

Exclusion Criteria

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Stem Cell Transplant

An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT

The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial