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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: Completed Phase 3 study, sponsored by Basilea Pharmaceutica.
NCT05856227 is a Phase 3 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest
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 |
What the finished NCT05856227 record still lists
NCT05856227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Ceftobiprole medocaril is the first listed.
NCT05856227 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05856227's enrollment target sits among peer trials
9 1992nd of 2000 higher than 8 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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