Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections (NCT NCT03445195)
NCT ID: NCT03445195
Last Updated: 2020-01-22
Results Overview
The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
From baseline through day 21
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
27
|
|
Overall Study
COMPLETED
|
51
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
n=53 Participants
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
n=27 Participants
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
|
28.09 Kg/m^2
STANDARD_DEVIATION 6.661 • n=5 Participants
|
28.63 Kg/m^2
STANDARD_DEVIATION 5.856 • n=7 Participants
|
28.27 Kg/m^2
STANDARD_DEVIATION 6.368 • n=5 Participants
|
|
Height
|
172.6 Centimeters
STANDARD_DEVIATION 8.81 • n=5 Participants
|
173.1 Centimeters
STANDARD_DEVIATION 8.44 • n=7 Participants
|
172.8 Centimeters
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Weight
|
83.79 Kilograms
STANDARD_DEVIATION 20.644 • n=5 Participants
|
85.76 Kilograms
STANDARD_DEVIATION 17.929 • n=7 Participants
|
84.45 Kilograms
STANDARD_DEVIATION 19.677 • n=5 Participants
|
|
Screening Creatinine Clearance
|
94.3 Milliliters per minute
STANDARD_DEVIATION 23.76 • n=5 Participants
|
91.7 Milliliters per minute
STANDARD_DEVIATION 18.19 • n=7 Participants
|
93.4 Milliliters per minute
STANDARD_DEVIATION 21.96 • n=5 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 17.55 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 15.92 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 17.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline through day 21The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.
Outcome measures
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
n=47 Participants
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
n=21 Participants
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
|---|---|---|
|
Number of Participants With Overall Success
|
36 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 21Population: The number analyzed for each population is different as the efficacy outcome is for the proportion of subjects with a clinical cure for each group.
Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.
Outcome measures
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
n=53 Participants
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
n=27 Participants
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
|---|---|---|
|
Clinical Cure
MITT population
|
52 Participants
|
27 Participants
|
|
Clinical Cure
m-MITT population
|
46 Participants
|
21 Participants
|
|
Clinical Cure
CE population
|
52 Participants
|
27 Participants
|
|
Clinical Cure
ME population
|
45 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 21Population: The analysis population differs for each group because the efficacy endpoint is for specific populations.
Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit
Outcome measures
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
n=53 Participants
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
n=27 Participants
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
|---|---|---|
|
Microbiologic Eradication
m-MITT population
|
37 Participants
|
17 Participants
|
|
Microbiologic Eradication
ME population
|
36 Participants
|
17 Participants
|
Adverse Events
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo + Imipenem/Cilastatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin
n=53 participants at risk
Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
Placebo + Imipenem/Cilastatin
n=27 participants at risk
Placebo: Matching 1g IV solution.
Imipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.4%
5/53 • Number of events 5 • 48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU)
|
7.4%
2/27 • Number of events 2 • 48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU)
|
|
Vascular disorders
Phlebitis
|
5.7%
3/53 • Number of events 3 • 48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU)
|
3.7%
1/27 • Number of events 1 • 48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60