A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
30actual
Sites
4
Countries
South Africa, Taiwan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-14 | actual | When the study began enrolling |
| Primary completion | 2025-03-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-31 | actual | The whole study's end, after follow-up |
| First posted | 2023-10-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Gram-Negative Bacterial Infections
Interventions
- Drug: Cefiderocol — also filed as S-649266
- Drug: Standard of Care
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
measured Up to 8 hours postdose
Cmax After a Minimum of 4 Doses of Cefiderocol
measured Up to 8 hours postdose
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
measured Up to 8 hours postdose
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
measured Up to 3 hours
Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
measured Up to 8 hours postdose
Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
measured Up to 8 hours postdose
Publications
- PMID 39230271 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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