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

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ClinicalTrials.gov Identifier: NCT02600611
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Motif Bio

Tracking Information
First Submitted Date  ICMJE November 5, 2015
First Posted Date  ICMJE November 9, 2015
Results First Submitted Date  ICMJE March 20, 2018
Results First Posted Date  ICMJE June 19, 2018
Last Update Posted Date June 19, 2018
Actual Study Start Date  ICMJE November 1, 2015
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2018)
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. [ Time Frame: Baseline and 48-72 hours after first dose of study drug ]
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). [ Time Frame: 48 to 72 hours after first dose of study drug ]
Change History Complete list of historical versions of study NCT02600611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2018)
Resolution or Near Resolution of Lesion at Test of Cure Visit [ Time Frame: 7 to14 days after the end of treatment ]
Resolution or near resolution of lesion at Test of Cure (TOC) visit
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Skin Structures and Soft Tissue Infections
Intervention  ICMJE
  • Drug: iclaprim
    Experimental treatment
    Other Name: MTF-100
  • Drug: vancomycin
    Active comparator
    Other Name: Vancocin
Study Arms  ICMJE
  • Experimental: iclaprim
    iclaprim 80 mg intravenous every 12 hours
    Intervention: Drug: iclaprim
  • Active Comparator: vancomycin
    vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
    Intervention: Drug: vancomycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2015)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2017
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Chile,   Colombia,   Germany,   Latvia,   Peru,   Poland,   Puerto Rico,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02600611
Other Study ID Numbers  ICMJE ICL-23-ABSSSI1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Motif Bio
Study Sponsor  ICMJE Motif Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Huang, MD, PhD Motif BioSciences
PRS Account Motif Bio
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP