Trials / Completed
CompletedNCT06086626
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-03-14
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
- First posted
- 2023-10-17
- Last updated
- 2026-03-02
Locations
4 sites across 3 countries: United States, South Africa, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06086626. Inclusion in this directory is not an endorsement.