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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

NCT06086626•Shionogi

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
•2. Hospitalized infants from birth to \< 3 months (\< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
•3. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
•4. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection

Exclusion Criteria

•1. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
•2. Life expectancy of \< 72 hours after enrollment
•3. Urine output \< 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
•4. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1
•5. Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles\[μmol\]/liter \[L\]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
•6. Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
•7. 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
•8. Receiving renal replacement therapy
•9. Received any other investigational medicinal product within 30 days of study drug administration
•10. Receiving treatment with a vasopressor at Screening
+3 more criteria

Locations (4)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Duke University

Durham, North Carolina, United States

Tygerberg Hospital

Cape Town, Western Cape, South Africa

Chang Gung Memorial Hospital, Linkou Department of Pediatrics

Taoyuan, Taiwan

Key Dates

Start Date

March 14, 2024

Primary Completion Date

March 31, 2025

Completion Date

March 31, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Gram-Negative Bacterial Infections

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

NCT06135350

Gram Negative PneumoniaGram-Negative Bacterial Infections+1 more

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COMPLETEDPHASE2

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

NCT04335539

Gram-negative Bacterial InfectionsBloodstream Infections (BSI)+5 more

View study

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: March 2, 2026Data 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 Neonates and Infants

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 Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

A Study to Assess the Safety, Tolerability, and Pharmacokinetics 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