Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

Skin Structures and Soft Tissue Infections Clinical Trial

— REVIVE-1  

Official title:

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-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600611
• Other study ID #: ICL-23-ABSSSI1
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2015
• Est. completion date: January 30, 2017

Study information

• Verified date: April 2018
• Source: Motif Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. written informed consent;

2. =18 years of age;

3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;

2. infected diabetic foot ulcers;

3. infected decubitus ulcers;

4. necrotizing fasciitis or gangrene;

5. uncomplicated skin or skin structure infection;

6. infections associated with a prosthetic device;

7. suspected or confirmed osteomyelitis;

8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.

Related Conditions & MeSH terms

• Skin Structures and Soft Tissue Infections
• Soft Tissue Infections

Intervention

Drug:
• iclaprim
Experimental treatment
• vancomycin
Active comparator

Locations

Country	Name	City	State
Bulgaria	Bulgaria	Sofia	Sofia-Grad
Bulgaria	Bulgaria	Sofia
Chile	Chile	Temuco
Colombia	Colombia	Barranquilla
Germany	Germany	Dessau
Germany	Germany	Koeln	Northwest
Germany	Germany	Mainz
Germany	Germany	Munster
Latvia	Latvia	Daugavpils
Latvia	Latvia	Liepaja
Latvia	Latvia	Rezekne
Latvia	Latvia	Riga
Latvia	Latvia	Riga
Peru	Peru	Cerro De Pasco	LIM
Peru	Peru	Cusco
Peru	Peru	Ica
Peru	Peru	La Libertad
Peru	Peru	Lima
Peru	Peru	Lima
Peru	Peru	Lima
Peru	Peru	Piura
Peru	Peru	San Borja
Peru	Peru	San Juan de Miraflores
Poland	Poland	Bydgoszcz
Poland	Poland	Olsztyn
Poland	Poland	Warszawa
Poland	Poland	Wroclaw
Puerto Rico	Puerto Rico	Ponce
Puerto Rico	Puerto Rico	Rio Grande
Ukraine	Ukraine	Cherkasy
Ukraine	Ukraine	Ivano Frankivsk
Ukraine	Ukraine	Ivano-Frankivsk
Ukraine	Ukraine	Khar'kov
Ukraine	Ukraine	Kharkiv
Ukraine	Ukraine	Kiev
Ukraine	Ukraine	Odessa
Ukraine	Ukraine	Odessa
Ukraine	Ukraine	Zaporizhzhya
Ukraine	Ukraine	Zaporizhzhya
Ukraine	Ukraine	Zaporizhzhya
United States	California	Buena Park	California
United States	Texas	Channelview	Texas
United States	Florida	DeLand	Florida
United States	Tennessee	Franklin	Tennessee
United States	Tennessee	Franklin	Tennessee
United States	Indiana	Indianapolis	Indiana
United States	California	La Mesa	California
United States	Nebraska	Lincoln	Nebraska
United States	California	Long Beach	California
United States	Texas	McAllen	Texas
United States	Florida	Miami	Florida
United States	California	Modesto	California
United States	California	Oceanside	California
United States	Washington	Seattle	Washington
United States	California	Torrance	California
United States	District of Columbia	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Motif Bio

Countries where clinical trial is conducted

United States,  Bulgaria,  Chile,  Colombia,  Germany,  Latvia,  Peru,  Poland,  Puerto Rico,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.	=20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).	Baseline and 48-72 hours after first dose of study drug
Secondary	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