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-2
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 613
- Locations
- 19
- Primary Endpoint
- Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
Study Overview
Brief 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.
Detailed Description
This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
iclaprim
iclaprim 80 mg intravenous every 12 hours
Intervention: Iclaprim (Drug)
vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Intervention: Vancomycin (Drug)
Outcomes
Primary Outcomes
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
Time Frame: Baseline and 48 to 72 hours after first dose of study drug
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).
Secondary Outcomes
- Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit(7 to14 days after the end of treatment)