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Trial record 68 of 528 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT02607618
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : July 11, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Motif Bio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Structures and Soft Tissue Infections
Interventions Drug: Iclaprim
Drug: Vancomycin
Enrollment 613
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iclaprim Vancomycin
Hide Arm/Group Description

iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment

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

Vancomycin: Active comparator

Period Title: Overall Study
Started 306 307
Completed 295 305
Not Completed 11 2
Arm/Group Title Iclaprim Vancomycin Total
Hide Arm/Group Description

iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment

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

Vancomycin: Active comparator

Total of all reporting groups
Overall Number of Baseline Participants 295 305 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 305 participants 600 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
240
  81.4%
250
  82.0%
490
  81.7%
>=65 years
55
  18.6%
55
  18.0%
110
  18.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 305 participants 600 participants
50.0  (15.7) 50.8  (15.0) 50.4  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 305 participants 600 participants
Female
103
  34.9%
108
  35.4%
211
  35.2%
Male
192
  65.1%
197
  64.6%
389
  64.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 305 participants 600 participants
Hispanic or Latino
99
  33.6%
94
  30.8%
193
  32.2%
Not Hispanic or Latino
193
  65.4%
207
  67.9%
400
  66.7%
Unknown or Not Reported
3
   1.0%
4
   1.3%
7
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 305 participants 600 participants
American Indian or Alaska Native
2
   0.7%
3
   1.0%
5
   0.8%
Asian
1
   0.3%
1
   0.3%
2
   0.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
3
   1.0%
4
   0.7%
Black or African American
12
   4.1%
11
   3.6%
23
   3.8%
White
267
  90.5%
276
  90.5%
543
  90.5%
More than one race
0
   0.0%
2
   0.7%
2
   0.3%
Unknown or Not Reported
12
   4.1%
9
   3.0%
21
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 295 participants 305 participants 600 participants
Argentina 9 3 12
Romania 20 14 34
Turkey 5 7 12
Belgium 2 0 2
Hungary 4 5 9
United States 200 205 405
Czechia 4 3 7
Portugal 3 5 8
Estonia 36 48 84
Croatia 10 12 22
Mexico 2 3 5
1.Primary Outcome
Title Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iclaprim Vancomycin
Hide Arm/Group Description:

iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment

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

Vancomycin: Active comparator

Overall Number of Participants Analyzed 295 305
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.3
(73.2 to 82.9)
76.7
(71.6 to 81.3)
2.Secondary Outcome
Title Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit
Hide Description Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.
Time Frame 7 to14 days after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iclaprim Vancomycin
Hide Arm/Group Description:

iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment

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

Vancomycin: Active comparator

Overall Number of Participants Analyzed 295 305
Measure Type: Number
Unit of Measure: participants
229 237
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iclaprim Vancomycin
Hide Arm/Group Description

iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment

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

Vancomycin: Active comparator

All-Cause Mortality
Iclaprim Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/299 (0.00%)      1/302 (0.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Iclaprim Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/299 (0.00%)      1/302 (0.33%)    
Renal and urinary disorders     
Renal and urinary disorders  [1]  0/299 (0.00%)  1/302 (0.33%) 
Indicates events were collected by systematic assessment
[1]
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iclaprim Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/299 (0.00%)      1/302 (0.33%)    
Renal and urinary disorders     
Product Issues   0/299 (0.00%)  0 1/302 (0.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Noviello
Organization: Motif BioSciences
Phone: 908-432-7802
EMail: stephanie.noviello@motifbio.com
Layout table for additonal information
Responsible Party: Motif Bio
ClinicalTrials.gov Identifier: NCT02607618     History of Changes
Other Study ID Numbers: ICL-24-ABSSSI2
First Submitted: November 13, 2015
First Posted: November 18, 2015
Results First Submitted: June 14, 2018
Results First Posted: July 11, 2018
Last Update Posted: August 7, 2018