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NCT02052388 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
A Phase 2 study of Bacterial Infection and Skin Infection, sponsored by Cellceutix Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
- 4
- Study locations
NCT02052388: Completed Phase 2 study of Bacterial Infection and Skin Infection, sponsored by Cellceutix Corporation.
NCT02052388 is a Phase 2 study of Bacterial Infection and Skin Infection that has completed, run by Cellceutix Corporation. The registered enrollment target is 215 participants, above the 79-participant average among 8 other Bacterial Infection trials with a reported enrollment target (172% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052388, a Phase 2 study of Bacterial Infection and Skin Infection, has completed, sponsored by Cellceutix Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine the safety and efficacy of three different dosing regimens of brilacidin compared to daptomycin for the treatment of serious skin infections. This study will aid in selecting the appropriate dose of brilacidin for later stage studies.
Primary Outcome
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by ≥20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.
Conditions Studied
Interventions
- DRUG Daptomycin
- DRUG Brilacidin
Study Locations (4)
California
- eStudy Site - Chula Vista
- eStudy Site - La Mesa
- eStudy Site - Oceanside
Nevada
- eStudy Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT02052388 record still lists
NCT02052388 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 8 other Bacterial Infection trials with a reported enrollment target (172% higher).
The record links to 2 conditions, with Bacterial Infection appearing as the primary indexed condition, and to 2 interventions - of which Daptomycin is the first listed.
NCT02052388 reports a single indexed study location in California, Nevada.
Frequently Asked Questions
What is clinical trial NCT02052388 about?
NCT02052388 is a clinical study titled "Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections". The purpose of this study is to determine the safety and efficacy of three different dosing regimens of brilacidin compared to daptomycin for the treatment of serious skin infections. This study will aid in selecting the appropriate dose of brilacidin for later stage studies.
What is the current status of trial NCT02052388?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2014-02. Estimated completion is 2014-10.
What conditions does trial NCT02052388 study?
This clinical trial studies the following conditions: Bacterial Infection, Skin Infection.
What interventions are being tested in trial NCT02052388?
The interventions under investigation include: Daptomycin (DRUG), Brilacidin (DRUG).
Who is sponsoring clinical trial NCT02052388?
This trial is sponsored by Cellceutix Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02052388 being conducted?
This trial has 4 study locations across California, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02052388's enrollment target sits among peer trials
215 1st of 8 higher than 8 of 8 other Bacterial Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infection 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.
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