Trial · Interventional
CompletedPhase 2Registry dataEfficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 215 participants (actual)
- Sponsor
- Cellceutix Corporation · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Feb 2014
- Primary completion
- Oct 2014
- Completion
- Oct 2014
- First posted
- 3 Feb 2014 (estimated)
- Last update posted
- 26 Sept 2018
- Conditions
- Skin Infection · Bacterial Infection
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
NCT02052388Feb 2014 to Oct 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- DaptomycinDrug
- BrilacidinDrug
Arms4
Experimental
Low Single Dose Brilacidin
0.6mg/kg Brilacidin IV (single dose)
Experimental
High Single Dose Brilacidin
0.8mg/kg Brilacidin IV (single dose)
Experimental
3-Day Regimen Brilacidin
0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 \& 3
Active comparator
Standard dosing regimen Daptomycin
4mg/kg Daptomycin IV daily for 7 Days
Primary outcomes1
Outcomes the sponsor listed as primary.
Early clinical response
Time frame · 48-72 hours after first dose of study drug
Registry description
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.
Secondary outcomes(2)
Clinical Response
Time frame · Day 7-8; Day 10-14; Day 21-28
Registry description
For Days 7/8 and 10-14, a response of Clinical Success will be assigned if all signs and symptoms of infection present at baseline have improved and/or resolved and no additional antibiotics are considered necessary. Subjects who have a response of Clinical Success at Day 10-14 will be assessed for sustained efficacy at Day 21-28. A response of Sustained Clinical Success will be assigned if all signs and symptoms remain resolved and no additional antibiotics are considered necessary. If signs and symptoms of infection recurred at the original site of infection and require additional antibiotic therapy, a response of Relapse will be assigned.
Microbiological response
Time frame · 48-72 hours; Day 7-8; Day 10-14
Registry description
Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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