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

Skin Structures and Soft Tissue Infections Clinical Trial

— REVIVE-2  

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-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607618
• Other study ID #: ICL-24-ABSSSI2
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: August 8, 2017

Study information

• Verified date: June 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 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
Argentina	Argentina	Buenos Aires
Argentina	Argentina	Ciudad Autonoma de Buenos Aires
Belgium	Belgium	Brussels
Belgium	Belgium	Brussels
Croatia	Croatia	Slavonski Brod
Croatia	Croatia	Zadar
Croatia	Croatia	Zagreb
Czechia	Czech Republic	Hradec Kralove
Czechia	Czech Republic	Ostrava
Czechia	Czech Republic	Pribram
Czechia	Czech Republic	Usti nad Labem
Estonia	Estonia	Kohtla-Jarve
Estonia	Estonia	Tallinn
Estonia	Estonia	Tallinn
Estonia	Estonia	Tartu
Estonia	Estonia	Voru
Hungary	Hungary	Budapest
Hungary	Hungary	Miskolc
Hungary	Hungary	Szeged
Hungary	Hungary	Szekesfehervar
Hungary	Hungary	Veszprem
Portugal	Portugal	Amadora
Portugal	Portugal	Braga
Portugal	Portugal	Porto
Portugal	Portugal	Santarem
Portugal	Portugal	Viana do Castelo
Romania	Romania	Arad
Romania	Romania	Bucharest
Romania	Romania	Bucharest
Romania	Romania	Bucuresti
Romania	Romania	Bucuresti
Romania	Romania	Cluj-Napoca
Romania	Romania	Craiova
Romania	Romania	Timisoara
Turkey	Turkey	Aydin
Turkey	Turkey	Istanbul
Turkey	Turkey	Trabzon
United States	California	Anaheim	California
United States	California	Buena Park	California
United States	Montana	Butte	Montana
United States	California	Chula Vista	California
United States	Georgia	Columbus	Georgia
United States	Florida	Hollywood	Florida
United States	Washington	Kennewick	Washington
United States	California	La Palma	California
United States	Nevada	Las Vegas	Nevada
United States	Ohio	Lima	Ohio
United States	California	Long Beach	California
United States	St. Mary Medical Center ER	Long Beach	California
United States	Florida	Miami	Florida
United States	Florida	Miami	Florida
United States	Washington	Richland	Washington
United States	Tennessee	Smyrna	Tennessee
United States	New Jersey	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Motif Bio

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Croatia,  Czechia,  Estonia,  Hungary,  Portugal,  Romania,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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