search
Back to results

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

Primary Purpose

Skin Structures and Soft Tissue Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Iclaprim
Vancomycin
Sponsored by
Motif Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Structures and Soft Tissue Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California
  • California
  • California
  • California
  • California
  • St. Mary Medical Center ER
  • Florida
  • Florida
  • Florida
  • Georgia
  • Montana
  • Nevada
  • New Jersey
  • Ohio
  • Tennessee
  • Washington
  • Washington
  • Argentina
  • Argentina
  • Belgium
  • Belgium
  • Croatia
  • Croatia
  • Croatia
  • Czech Republic
  • Czech Republic
  • Czech Republic
  • Czech Republic
  • Estonia
  • Estonia
  • Estonia
  • Estonia
  • Estonia
  • Hungary
  • Hungary
  • Hungary
  • Hungary
  • Hungary
  • Portugal
  • Portugal
  • Portugal
  • Portugal
  • Portugal
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Turkey
  • Turkey
  • Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iclaprim

vancomycin

Arm Description

iclaprim 80 mg intravenous every 12 hours

vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2015
Last Updated
July 10, 2018
Sponsor
Motif Bio
search

1. Study Identification

Unique Protocol Identification Number
NCT02607618
Brief Title
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 8, 2017 (Actual)
Study Completion Date
August 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Motif Bio

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Structures and Soft Tissue Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iclaprim
Arm Type
Experimental
Arm Description
iclaprim 80 mg intravenous every 12 hours
Arm Title
vancomycin
Arm Type
Active Comparator
Arm Description
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Intervention Type
Drug
Intervention Name(s)
Iclaprim
Other Intervention Name(s)
MTF-100
Intervention Description
Experimental treatment
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
Description
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).
Time Frame
Baseline and 48 to 72 hours after first dose of study drug
Secondary Outcome Measure Information:
Title
Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit
Description
Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.
Time Frame
7 to14 days after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Noviello, MD
Organizational Affiliation
Motif Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
California
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
California
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
California
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
California
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
California
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
St. Mary Medical Center ER
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Florida
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33130-2433
Country
United States
Facility Name
Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Georgia
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Montana
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
New Jersey
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Ohio
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Tennessee
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167-6826
Country
United States
Facility Name
Washington
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Washington
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Argentina
City
Buenos Aires
ZIP/Postal Code
C1430BKC
Country
Argentina
Facility Name
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1425DQK
Country
Argentina
Facility Name
Belgium
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Croatia
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Croatia
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Croatia
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Czech Republic
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Czech Republic
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Czech Republic
City
Usti nad Labem
ZIP/Postal Code
400 11
Country
Czechia
Facility Name
Estonia
City
Kohtla-Jarve
ZIP/Postal Code
31025
Country
Estonia
Facility Name
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Estonia
City
Tallinn
ZIP/Postal Code
31419
Country
Estonia
Facility Name
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Estonia
City
Voru
ZIP/Postal Code
65526
Country
Estonia
Facility Name
Hungary
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Portugal
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Portugal
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Portugal
City
Santarem
ZIP/Postal Code
2005-177
Country
Portugal
Facility Name
Portugal
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Romania
City
Arad
ZIP/Postal Code
310037
Country
Romania
Facility Name
Romania
City
Bucharest
ZIP/Postal Code
20475
Country
Romania
Facility Name
Romania
City
Bucharest
ZIP/Postal Code
41914
Country
Romania
Facility Name
Romania
City
Bucuresti
ZIP/Postal Code
42122
Country
Romania
Facility Name
Romania
City
Bucuresti
ZIP/Postal Code
50098
Country
Romania
Facility Name
Romania
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania
Facility Name
Romania
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Romania
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Turkey
City
Aydin
ZIP/Postal Code
9100
Country
Turkey
Facility Name
Turkey
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Turkey
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29783024
Citation
Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. 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. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19.
Results Reference
derived
PubMed Identifier
29530858
Citation
Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. 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). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs