Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
NCT ID: NCT03354598
Last Updated: 2021-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1671 participants
INTERVENTIONAL
2018-08-01
2020-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sulopenem-etzadroxil/probenecid
Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
Sulopenem-Etzadroxil/Probenecid
Treatment of uncomplicated urinary tract infection
Ciprofloxacin
Ciprofloxacin 250 mg PO administered twice daily for 3 days
Ciprofloxacin
Treatment of uncomplicated urinary tract infection
Interventions
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Sulopenem-Etzadroxil/Probenecid
Treatment of uncomplicated urinary tract infection
Ciprofloxacin
Treatment of uncomplicated urinary tract infection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
3. A mid-stream urine specimen with:
1. a dipstick analysis positive for nitrite AND
2. evidence of pyuria as defined by either:
i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine
4. Has given written informed consent to participate in the study.
Exclusion Criteria
2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
3. Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
4. Patients with ileal loops or urinary stoma
5. Patients with an indwelling urinary catheter in the previous 30 days
6. Patients with paraplegia
7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
8. Any history of trauma to the pelvis or urinary tract
9. Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
10. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
11. Known history of creatinine clearance \<50 mL/min
12. Patients known to have liver disease
13. Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
14. Patients with uncontrolled diabetes mellitus
15. Patients with history of blood dyscrasias
16. Patients with history of uric acid kidney stones
17. Patients with acute gouty attack
18. Patients on chronic methotrexate therapy
19. Patient known to be immunocompromised
20. Patients with a known history of myasthenia gravis
21. Patients who require concomitant administration of tizanidine or valproic acid
22. Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
23. Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
24. History of seizures
25. Use of any other investigational drug in the 30 days prior to the study
18 Years
FEMALE
No
Sponsors
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Iterum Therapeutics, International Limited
INDUSTRY
Responsible Party
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Locations
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Medical Facility
Birmingham, Alabama, United States
Medical Facility
Phoenix, Arizona, United States
Medical Facility
Tolleson, Arizona, United States
Medical Facility
Cerritos, California, United States
Medical Facility
Chula Vista, California, United States
Medical Facility
Fullerton, California, United States
Medical Facility
La Mesa, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
Medical Facility
Sylmar, California, United States
Medical Facility
Washington D.C., District of Columbia, United States
Medical Facility
Bradenton, Florida, United States
Medical Facility
Clearwater, Florida, United States
Medical Facility
Doral, Florida, United States
Medical Facility
Edgewater, Florida, United States
Medical Facility
Hialeah, Florida, United States
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Lauderdale Lakes, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Miami Springs, Florida, United States
Medical Facility
New Port Richey, Florida, United States
Medical Facility
Ormond Beach, Florida, United States
Medical Facility
Palmetto Bay, Florida, United States
Medical Facility
St. Petersburg, Florida, United States
Medical Facility
Winter Haven, Florida, United States
Medical Facility
Atlanta, Georgia, United States
Medical Facility
Norcross, Georgia, United States
Medical Facility
Perry, Georgia, United States
Medical Facility
Lake Charles, Louisiana, United States
Medical Facility
Metairie, Louisiana, United States
Medical Facility
New Orleans, Louisiana, United States
Medical Facility
Las Vegas, Nevada, United States
Medical Facility
Las Vegas, Nevada, United States
Medical Facility
Brooklyn, New York, United States
Medical Facility
Raleigh, North Carolina, United States
Medical Facility
Hugo, Oklahoma, United States
Medical Facility
Easley, South Carolina, United States
Medical Facility
Lancaster, South Carolina, United States
Medical Facility
Myrtle Beach, South Carolina, United States
Medical Facility
Austin, Texas, United States
Medical Facility
Austin, Texas, United States
Medical Facility
Carrollton, Texas, United States
Medical Facility
Corpus Christi, Texas, United States
Medical Facility
Dallas, Texas, United States
Medical Facility
Houston, Texas, United States
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Houston, Texas, United States
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Pearland, Texas, United States
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Plano, Texas, United States
Medical Facility
Sugar Land, Texas, United States
Medical Facility
Bountiful, Utah, United States
Medical Facility
Salt Lake City, Utah, United States
Medical Facility
Salt Lake City, Utah, United States
Medical Facility
South Jordan, Utah, United States
Medical Facility
St. George, Utah, United States
Countries
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References
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Dunne MW, Aronin SI, Das AF, Akinapelli K, Zelasky MT, Puttagunta S, Boucher HW. Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):66-77. doi: 10.1093/cid/ciac738.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IT001-301
Identifier Type: -
Identifier Source: org_study_id
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