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

NCT ID: NCT06086626

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2025-03-31

Brief 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.

Conditions

Gram-Negative Bacterial Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Dose Cefiderocol

Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics

Group Type: EXPERIMENTAL

Cefiderocol

Intervention Type: DRUG

Administered via intravenous (IV) infusion

Standard of Care

Intervention Type: DRUG

Antibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards

Multiple-Dose Cefiderocol

Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics

Group Type: EXPERIMENTAL

Standard of Care

Intervention Type: DRUG

Antibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards

Interventions

Cefiderocol

Administered via intravenous (IV) infusion

Intervention Type: DRUG

Standard of Care

Antibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards

Intervention Type: DRUG

Other Intervention Names

S-649266

Eligibility Criteria

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

11. Has a confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection

12. Anticipated need for antibacterial therapy longer than 14 days (example , osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram-positive organisms or multidrug resistant Gram-negative organisms

13. Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Shionogi

Locations

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

Countries

United States; South Africa; Taiwan

References

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.

Reference Type: DERIVED

PMID: 39230271 (View on PubMed)

Other Identifiers

1904R2136

Identifier Type: -

Identifier Source: org_study_id