Trials / Terminated
TerminatedNCT02527681
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
Summary
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceftobiprole medocaril | Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril. |
Timeline
- Start date
- 2016-11-22
- Primary completion
- 2020-02-25
- Completion
- 2020-02-25
- First posted
- 2015-08-19
- Last updated
- 2023-06-05
- Results posted
- 2021-01-06
Locations
14 sites across 6 countries: United States, Belgium, Germany, Latvia, Lithuania, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02527681. Inclusion in this directory is not an endorsement.