Clinical Trial: Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Brief 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.

Detailed Summary:

This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of three regimens of brilacidin compared to an active control, daptomycin, in subjects with ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as either inpatients or outpatients.

Eligible subjects will be randomized to one of 4 treatment groups in a 1:1:1:1 ratio. Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6 mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6 mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily placebo. Subjects randomized to daptomycin will receive 7 days of treatment. Subjects will be assessed for both clinical and microbiologic efficacy 48-72 hours after the first dose of study drug. After an assessment at Day 7-8, subjects will be again be evaluated for efficacy at Day 10-14 and via a phone contact at Day 21-28.

Approximately 200 subjects randomized in a 1:1:1:1 ratio to receive one of the three brilacidin regimens or daptomycin will be evaluable. The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the Intent-to treat (ITT) population. Additional efficacy and safety analyses will be performed.


Sponsor: Cellceutix Corporation

Current Primary Outcome: Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Response [ Time Frame: Day 7-8; Day 10-14; Day 21-28 ]

    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 ]
    Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)


Original Secondary Outcome: Same as current

Information By: Cellceutix Corporation

Dates:
Date Received: January 30, 2014
Date Started: February 2014
Date Completion:
Last Updated: May 19, 2015
Last Verified: August 2014