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NCT05856227 · ClinicalTrials.gov registry record · Phase 3
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
A Phase 3 study, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT05856227 is a Phase 3 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 9 participants.
The verdict
NCT05856227, a Phase 3 study, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.
Interventions
- DRUG Ceftobiprole medocaril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-08-06 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05856227
The ClinicalTrials.gov registry entry for NCT05856227 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ceftobiprole medocaril is the first listed.
NCT05856227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05856227 about?
NCT05856227 is a clinical study titled "Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age". This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved fo...
What is the current status of trial NCT05856227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2023-08-06. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT05856227?
The interventions under investigation include: Ceftobiprole medocaril (DRUG).
Who is sponsoring clinical trial NCT05856227?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
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