A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS ICLAPRIM VERSUS VANCOMYCIN IN THE TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS SUSPECTED OR CONFIRMED TO BE DUE TO GRAM-POSITIVE PATHOGENS. REVIVE-1

Not Applicable

• Conditions: -L00 Staphylococcal scalded skin syndrome; Staphylococcal scalded skin syndrome; L00

• Registration Number: PER-013-16
• Lead Sponsor: Motif BioSciences Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

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 with major cutaneous abscess, cellulitis/erysipelas, and/or wound infections (caused by external trauma)and the presence of purulent or seropurulent drainage before or after surgical intervention of a wound or at least 3 of the following signs and symptoms: discharge, erythema (extending at least 2 cm beyond a wound edge in one direction), swelling and/or induration, heat and/or localized warmth, and/or pain and/or tenderness to palpation.

Exclusion Criteria

ABSSSI of the following categories: severely impaired arterial blood supply such that amputation of the infected anatomical site is likely, infected diabetic foot ulcers, infected decubitus ulcers, infected human or animal bites, necrotizing fasciitis or gangrene, uncomplicated skin or skin structure infection, self-limiting infections, skin and/or skin structure infection that can be treated by surgery alone, infections associated with a prosthetic device, and suspected or confirmed osteomyelitis; known or suspected concurrent infection or conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy; received more than one dose of a short-acting (i.e., q12h dosing or less) systemic antibiotic(s) active against Gram-positive pathogens within the last 7 days, unless there is documented evidence of treatment failure OR demonstrated resistance of Gram-positive pathogens to the prior antibiotic therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified