Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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 600
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 300 300
Completed 298 300
Not Completed 2 0
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 298 300 598
Hide Baseline Analysis Population Description
Intent to Treat Population (all patients randomized)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
240
  80.5%
240
  80.0%
480
  80.3%
>=65 years
58
  19.5%
60
  20.0%
118
  19.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 298 participants 300 participants 598 participants
46.4  (13.3) 48.2  (14.8) 47.8  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
Female
109
  36.6%
129
  43.0%
238
  39.8%
Male
189
  63.4%
171
  57.0%
360
  60.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
Hispanic or Latino
32
  10.7%
31
  10.3%
63
  10.5%
Not Hispanic or Latino
266
  89.3%
269
  89.7%
535
  89.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   1.3%
7
   2.3%
11
   1.8%
White
266
  89.3%
269
  89.7%
535
  89.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
28
   9.4%
24
   8.0%
52
   8.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 300 participants 598 participants
Latvia
4
   1.3%
4
   1.3%
8
   1.3%
Puerto Rico
1
   0.3%
1
   0.3%
2
   0.3%
United States
219
  73.5%
200
  66.7%
419
  70.1%
Ukraine
11
   3.7%
11
   3.7%
22
   3.7%
Bulgaria
1
   0.3%
1
   0.3%
2
   0.3%
Peru
2
   0.7%
3
   1.0%
5
   0.8%
1.Primary Outcome
Title ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
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 48-72 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients (ITT).
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 298 300
Measure Type: Number
Unit of Measure: percentage of participants
80.9 81.0
2.Secondary Outcome
Title 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
all randomized patients (ITT population)
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 298 300
Measure Type: Number
Unit of Measure: participants
248 262
Time Frame 1 year
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   0/298 (0.00%)   2/300 (0.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Iclaprim Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   9/298 (3.02%)   14/300 (4.67%) 
Renal and urinary disorders     
SAEs  [1]  9/298 (3.02%)  14/300 (4.67%) 
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 (%) Affected / at Risk (%)
Total   151/298 (50.67%)   128/300 (42.67%) 
Product Issues     
Adverse effects  [1]  151/298 (50.67%)  128/300 (42.67%) 
Indicates events were collected by systematic assessment
[1]
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
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
Name/Title: David Huang
Organization: Motif BioSciences
Phone: 936-577-5770
Responsible Party: Motif Bio
ClinicalTrials.gov Identifier: NCT02600611     History of Changes
Other Study ID Numbers: ICL-23-ABSSSI1
First Submitted: November 5, 2015
First Posted: November 9, 2015
Results First Submitted: March 20, 2018
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018