Title
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-1
Phase
Phase 3Lead Sponsor
Motif BioSciencesStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Skin Structures and Soft Tissue InfectionsIntervention/Treatment
iclaprim vancomycin ...Study Participants
600This 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.
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).
Experimental treatment
Active comparator
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
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.
| Event Type | Organ System | Event Term | Iclaprim | Vancomycin |
|---|
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).
Resolution or near resolution of lesion at Test of Cure (TOC) visit
