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

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
  • California
  • District of Columbia
  • Florida
  • Florida
  • Indiana
  • Nebraska
  • Tennessee
  • Tennessee
  • Texas
  • Texas
  • Washington
  • Bulgaria
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Germany
  • Germany
  • Germany
  • Latvia
  • Latvia
  • Latvia
  • Latvia
  • Latvia
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Peru
  • Poland
  • Poland
  • Poland
  • Poland
  • Puerto Rico
  • Puerto Rico
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine
  • Ukraine

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

≥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).

Secondary Outcome Measures

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 5, 2015
Last Updated
May 19, 2018
Sponsor
Motif Bio
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1. Study Identification

Unique Protocol Identification Number
NCT02600611
Brief Title
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 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 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).

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
600 (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
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
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 48-72 hours after first dose of study drug
Secondary Outcome Measure Information:
Title
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
David Huang, MD, PhD
Organizational Affiliation
Motif BioSciences
Official's Role
Study Director
Facility Information:
Facility Name
California
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
California
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
California
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
California
City
Modesto
State/Province
California
ZIP/Postal Code
95350-449
Country
United States
Facility Name
California
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
California
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
District of Columbia
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Florida
City
DeLand
State/Province
Florida
ZIP/Postal Code
32770-0834
Country
United States
Facility Name
Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510-2462
Country
United States
Facility Name
Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37094
Country
United States
Facility Name
Texas
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
Texas
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Bulgaria
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Chile
City
Temuco
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Colombia
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Germany
City
Koeln
State/Province
Northwest
ZIP/Postal Code
50937
Country
Germany
Facility Name
Germany
City
Dessau
ZIP/Postal Code
6847
Country
Germany
Facility Name
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Germany
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Latvia
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Latvia
City
Liepaja
ZIP/Postal Code
LV3414
Country
Latvia
Facility Name
Latvia
City
Rezekne
ZIP/Postal Code
4600
Country
Latvia
Facility Name
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Latvia
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Peru
City
Cerro De Pasco
State/Province
LIM
ZIP/Postal Code
1
Country
Peru
Facility Name
Peru
City
Cusco
Country
Peru
Facility Name
Peru
City
Ica
Country
Peru
Facility Name
Peru
City
La Libertad
Country
Peru
Facility Name
Peru
City
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
Peru
City
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Peru
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Peru
City
Piura
Country
Peru
Facility Name
Peru
City
San Borja
Country
Peru
Facility Name
Peru
City
San Juan de Miraflores
ZIP/Postal Code
29
Country
Peru
Facility Name
Poland
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Poland
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Puerto Rico
City
Ponce
ZIP/Postal Code
780
Country
Puerto Rico
Facility Name
Puerto Rico
City
Rio Grande
ZIP/Postal Code
745
Country
Puerto Rico
Facility Name
Ukraine
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Ukraine
City
Ivano Frankivsk
ZIP/Postal Code
7608
Country
Ukraine
Facility Name
Ukraine
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Ukraine
City
Khar'kov
ZIP/Postal Code
6100
Country
Ukraine
Facility Name
Ukraine
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Ukraine
City
Kiev
ZIP/Postal Code
3110
Country
Ukraine
Facility Name
Ukraine
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Ukraine
City
Odessa
ZIP/Postal Code
65082
Country
Ukraine
Facility Name
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69032
Country
Ukraine
Facility Name
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
29281036
Citation
Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987.
Results Reference
derived

Learn more about this trial

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

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