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NCT02426918 · ClinicalTrials.gov registry record · Phase 2
Study of Debio 1450 for Bacterial Skin Infections
A Phase 2 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 2
- Development phase
- 330
- Enrollment target
NCT02426918: Completed Phase 2 study, sponsored by Debiopharm International.
NCT02426918 is a Phase 2 study that has completed, run by Debiopharm International. The registered enrollment target is 330 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (148% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02426918, a Phase 2 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 330 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.
Primary Outcome
ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.
Interventions
- DRUG Linezolid
- DRUG Debio 1450 IV
- DRUG Debio 1450 Oral
- DRUG Debio 1450 Oral Placebo
- DRUG Linezolid Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT02426918 record still lists
NCT02426918 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (148% higher).
The record links to 0 conditions, and to 5 interventions - of which Linezolid is the first listed.
NCT02426918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02426918 about?
NCT02426918 is a clinical study titled "Study of Debio 1450 for Bacterial Skin Infections". The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.
What is the current status of trial NCT02426918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 330 participants. The study started on 2015-05. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02426918?
The interventions under investigation include: Linezolid (DRUG), Debio 1450 IV (DRUG), Debio 1450 Oral (DRUG), Debio 1450 Oral Placebo (DRUG), Linezolid Placebo (DRUG).
Who is sponsoring clinical trial NCT02426918?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02426918's enrollment target sits among peer trials
330 145th of 2000 higher than 1,855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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