Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections (NCT02052388) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
United States215 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A post-traumatic or post-surgical wound infection, occurring within 30 days of the trauma or surgery, characterized by purulent or seropurulent drainage from the wound and surrounding erythema, edema and/or induration of a minimum surface area of 75 cm2.
✓. A major cutaneous abscess, characterized by a collection of pus within the dermis or deeper tissues, accompanied by erythema, edema, and/or induration of a minimum surface area of 75 cm2. Note: patients with major cutaneous abscess will be limited to 30% of total enrollment
✓. Cellulitis/erysipelas, characterized by spreading areas of erythema, edema, and/or induration of a minimum surface area of 75 cm2.
✓. Purulent or seropurulent drainage or discharge
✓. Erythema
✓. Fluctuance
✓. Heat or localized warmth
✓. Pain or tenderness to palpation
Exclusion criteria
✕. Presence of an uncomplicated skin or skin structure infection, such as folliculitis, furunculosis, or minor abscess likely to respond to incision and drainage alone
✕. Suspected or confirmed osteomyelitis
✕. Suspected or confirmed septic arthritis
✕. Suspected or confirmed infection caused exclusively by Gram-negative pathogens or by any anaerobes
What they're measuring
1
Early clinical response
Timeframe: 48-72 hours after first dose of study drug
✕. Shock or profound hypotension, defined as systolic blood pressure \<90 mm Hg or a decrease of \>40 mm Hg from baseline that is not responsive to fluid challenge;
✕. Hypothermia (core temperature \<35.6°C or \<96.1°F);
✕. Disseminated intravascular coagulation as evidenced by prothrombin time (PT) or activated partial thromboplastin time (aPTT) 2 times the upper limit of normal;