Phase 3
Completed N=613
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Skin Structures and Soft Tissue Infections
Source: ClinicalTrials.gov NCT02607618 ↗
Enrolled (actual)
613
Serious AEs
0.2%
Results posted
Jul 2018
Primary outcomePrimary: Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline — 78.3; 76.7 percentage of participants
◆ Published Evidence
Established
38citations · ~5 / year
A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study).
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.
Linked Publications (2)
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A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study).
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Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline |
78.3; 76.7 | — |
| SECONDARY Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit |
229; 237 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02607618) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.