MedTrace Logo

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

NCT06086626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-02

No results posted yet for this study

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

Interventions

DRUG

Cefiderocol

Administered via intravenous (IV) infusion

DRUG

Standard of Care

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

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Medical Director · Shionogi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06086626 on ClinicalTrials.gov