Trial Outcomes & Findings for Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women (NCT NCT05584657)
NCT ID: NCT05584657
Last Updated: 2024-11-20
Results Overview
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2229 participants
Primary outcome timeframe
Day 12+/-1 day
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
Sulopenem Etzadroxil/Probenecid
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
1111
|
1111
|
|
Overall Study
COMPLETED
|
1057
|
1063
|
|
Overall Study
NOT COMPLETED
|
54
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Baseline characteristics by cohort
| Measure |
Sulopenem Etzadroxil/Probenecid
n=522 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=468 Participants
Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
Total
n=990 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 17.31 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 17.18 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 17.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
522 Participants
n=5 Participants
|
468 Participants
n=7 Participants
|
990 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
333 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
419 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
789 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
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
522 participants
n=5 Participants
|
468 participants
n=7 Participants
|
990 participants
n=5 Participants
|
|
Diabetes
|
86 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiologic Modified Intent to Treat Population
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=522 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=468 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Overall Success
|
318 Participants
|
260 Participants
|
PRIMARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiological Modified intent-to-treat Susceptible Population
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=480 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=442 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Overall Success Susceptible Population
|
296 Participants
|
243 Participants
|
SECONDARY outcome
Timeframe: Day 12+/-1 dayPopulation: Modified Intent-to-treat Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=1107 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=1107 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Clinical Success Modified Intent-to-treat Population
|
851 Participants
|
849 Participants
|
SECONDARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiological Modified Intent-to-treat Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=522 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=468 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Clinical Success
|
397 Participants
|
358 Participants
|
SECONDARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiological Modified Intent-to-treat Susceptible Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=480 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=442 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Clinical Success Susceptible Population
|
371 Participants
|
339 Participants
|
SECONDARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiological Modified Intent-to-treat Population
Eradication of the Baseline Pathogen
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=522 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=468 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Microbiologic Success
|
390 Participants
|
315 Participants
|
SECONDARY outcome
Timeframe: Day 12+/-1 dayPopulation: Microbiological Modified Intent-to-treat Susceptible Population
Microbiologic Success: Eradication of the Baseline Pathogen
Outcome measures
| Measure |
Sulopenem Etzadroxil/Probenecid
n=480 Participants
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=442 Participants
Amoxicillin/clavulanate PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Microbiologic Success Susceptible Population
|
361 Participants
|
295 Participants
|
Adverse Events
Sulopenem Etzadroxil/Probenecid
Serious events: 0 serious events
Other events: 198 other events
Deaths: 0 deaths
Amoxicillin/Clavulanate
Serious events: 5 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulopenem Etzadroxil/Probenecid
n=1107 participants at risk
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=1107 participants at risk
Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1107 • 28 days
|
0.09%
1/1107 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1107 • 28 days
|
0.09%
1/1107 • Number of events 1 • 28 days
|
|
Infections and infestations
Genital herpes
|
0.00%
0/1107 • 28 days
|
0.09%
1/1107 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1107 • 28 days
|
0.09%
1/1107 • Number of events 1 • 28 days
|
|
General disorders
Chest pain
|
0.00%
0/1107 • 28 days
|
0.09%
1/1107 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
Sulopenem Etzadroxil/Probenecid
n=1107 participants at risk
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days
|
Amoxicillin/Clavulanate
n=1107 participants at risk
Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days
Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.1%
90/1107 • Number of events 90 • 28 days
|
4.1%
45/1107 • Number of events 45 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
4.3%
48/1107 • Number of events 48 • 28 days
|
4.3%
48/1107 • Number of events 48 • 28 days
|
|
Nervous system disorders
Headache
|
2.2%
24/1107 • Number of events 24 • 28 days
|
1.5%
17/1107 • Number of events 17 • 28 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.8%
20/1107 • Number of events 20 • 28 days
|
0.36%
4/1107 • Number of events 4 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
16/1107 • Number of events 16 • 28 days
|
0.36%
4/1107 • Number of events 4 • 28 days
|
Additional Information
Senior Vice President and Head of Clinical Development
Iterum Therapeutics
Phone: 8606614035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60