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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 ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS SUSPECTED OR CONFIRMED TO BE DUE TO GRAM-POSITIVE PATHOGENS. 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 ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS SUSPECTED OR CONFIRMED TO BE DUE TO GRAM-POSITIVE PATHOGENS. REVIVE-1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-013-16
Enrollment
132
Registered
2016-08-25
Start date
2016-06-16
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Iclaprim will be administered at a dose of 80 mg in 500 mL normal saline, infused over 2 hours q12h (every 12 hours) for 5 to 14 days. For subjects with moderate hepatic impairment (Child-Pugh Class B

Sponsors

Motif BioSciences Inc.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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 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

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.

Countries

Bulgaria, Chile, Colombia, Germany, Latovia, Peru, Poland, Ukraine, United States

Contacts

Public ContactFlor de Liz Jacome

COVANCE PERU SERVICES S.A.

liz.jacome@covance.com716-2679

Outcome results

None listed

Source: REPEC (via WHO ICTRP)