Trial Outcomes & Findings for Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2 (NCT NCT02607618)
NCT ID: NCT02607618
Last Updated: 2018-08-07
Results Overview
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
613 participants
Primary outcome timeframe
Baseline and 48 to 72 hours after first dose of study drug
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
Iclaprim
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
307
|
|
Overall Study
COMPLETED
|
295
|
305
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Baseline characteristics by cohort
| Measure |
Iclaprim
n=295 Participants
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
n=305 Participants
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
240 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
490 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 15.7 • n=99 Participants
|
50.8 years
STANDARD_DEVIATION 15.0 • n=107 Participants
|
50.4 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
389 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
99 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
400 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
267 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
543 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
9 participants
n=99 Participants
|
3 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
20 participants
n=99 Participants
|
14 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=99 Participants
|
205 participants
n=107 Participants
|
405 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Estonia
|
36 participants
n=99 Participants
|
48 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 48 to 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).
Outcome measures
| Measure |
Iclaprim
n=295 Participants
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
n=305 Participants
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
|---|---|---|
|
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
|
78.3 percentage of participants
Interval 73.2 to 82.9
|
76.7 percentage of participants
Interval 71.6 to 81.3
|
SECONDARY outcome
Timeframe: 7 to14 days after the end of treatmentResolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.
Outcome measures
| Measure |
Iclaprim
n=295 Participants
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
n=305 Participants
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
|---|---|---|
|
Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit
|
229 participants
|
237 participants
|
Adverse Events
Iclaprim
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vancomycin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Iclaprim
n=299 participants at risk
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
n=302 participants at risk
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
|---|---|---|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/299 • 1 month
|
0.33%
1/302 • 1 month
|
Other adverse events
| Measure |
Iclaprim
n=299 participants at risk
iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment
|
Vancomycin
n=302 participants at risk
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator
|
|---|---|---|
|
Renal and urinary disorders
Product Issues
|
0.00%
0/299 • 1 month
|
0.33%
1/302 • Number of events 1 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER