CompletedPhase 3

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

United States600 participantsStarted 2015-11-01

Plain-language summary

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. written informed consent;
✓. ≥18 years of age;
✓. a bacterial infection of the skin with a lesion size area of at least 75 cm2;
✓. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
✓. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion criteria

✕. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
✕. infected diabetic foot ulcers;
✕. infected decubitus ulcers;
✕. necrotizing fasciitis or gangrene;
✕. uncomplicated skin or skin structure infection;
✕. infections associated with a prosthetic device;
✕. suspected or confirmed osteomyelitis;
✕. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.

What they're measuring

≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.

Timeframe: Baseline and 48-72 hours after first dose of study drug

Trial details

NCT IDNCT02600611

SponsorMotif Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-30

Results submitted2018-03-20

View on ClinicalTrials.gov More Skin Structures and Soft Tissue Infections trials