A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
Completed · Phase 2
Conditions studied: Gram-Negative Bacterial Infections
In brief
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.
Key facts
- Study ID
- NCT06086626
- Run by
- Shionogi
- People needed
- 30
- Starts
- 2024-03-14
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2026-03-02
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 City, Taiwan
Full record on ClinicalTrials.gov
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