Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Skin Structures and Soft Tissue Infections

Intervention / Treatment
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* Drug: Iclaprim
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iclaprim<br>iclaprim 80 mg intravenous every 12 hours | Drug: Iclaprim<br>* Experimental treatment<br>* Other names: MTF-100;|
| Active Comparator: vancomycin<br>vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance | Drug: Vancomycin<br>* Active comparator<br>* Other names: Vancocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). | Baseline and 48 to 72 hours after first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit | Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit. | 7 to14 days after the end of treatment |