Uncomplicated Urinary Tract Infections Clinical Trial
Official title:
A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
| Verified date | December 2019 |
| Source | Iterum Therapeutics, International Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
| Status | Completed |
| Enrollment | 1671 |
| Est. completion date | January 20, 2020 |
| Est. primary completion date | January 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Female patients =18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI) 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: 1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical Facility | Atlanta | Georgia |
| United States | Medical Facility | Austin | Texas |
| United States | Medical Facility | Austin | Texas |
| United States | Medical Facility | Birmingham | Alabama |
| United States | Medical Facility | Bountiful | Utah |
| United States | Medical Facility | Bradenton | Florida |
| United States | Medical Facility | Brooklyn | New York |
| United States | Medical Facility | Carrollton | Texas |
| United States | Medical Facility | Cerritos | California |
| United States | Medical Facility | Chula Vista | California |
| United States | Medical Facility | Clearwater | Florida |
| United States | Medical Facility | Corpus Christi | Texas |
| United States | Medical Facility | Dallas | Texas |
| United States | Medical Facility | Doral | Florida |
| United States | Medical Facility | Easley | South Carolina |
| United States | Medical Facility | Edgewater | Florida |
| United States | Medical Facility | Fullerton | California |
| United States | Medical Facility | Hialeah | Florida |
| United States | Medical Facility | Houston | Texas |
| United States | Medical Facility | Houston | Texas |
| United States | Medical Facility | Hugo | Oklahoma |
| United States | Medical Facility | La Mesa | California |
| United States | Medical Facility | Lake Charles | Louisiana |
| United States | Medical Facility | Lancaster | South Carolina |
| United States | Medical Facility | Las Vegas | Nevada |
| United States | Medical Facility | Las Vegas | Nevada |
| United States | Medical Facility | Lauderdale Lakes | Florida |
| United States | Medical Facility | Los Angeles | California |
| United States | Medical Facility | Metairie | Louisiana |
| 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 | Myrtle Beach | South Carolina |
| United States | Medical Facility | New Orleans | Louisiana |
| United States | Medical Facility | New Port Richey | Florida |
| United States | Medical Facility | Norcross | Georgia |
| United States | Medical Facility | Ormond Beach | Florida |
| United States | Medical Facility | Palmetto Bay | Florida |
| United States | Medical Facility | Pearland | Texas |
| United States | Medical Facility | Perry | Georgia |
| United States | Medical Facility | Phoenix | Arizona |
| United States | Medical Facility | Plano | Texas |
| United States | Medical Facility | Raleigh | North Carolina |
| United States | Medical Facility | Saint George | Utah |
| United States | Medical Facility | Saint Petersburg | Florida |
| United States | Medical Facility | Salt Lake City | Utah |
| United States | Medical Facility | Salt Lake City | Utah |
| United States | Medical Facility | San Diego | California |
| United States | Medical Facility | South Jordan | Utah |
| United States | Medical Facility | Sugar Land | Texas |
| United States | Medical Facility | Sylmar | California |
| United States | Medical Facility | Tolleson | Arizona |
| United States | Medical Facility | Washington | District of Columbia |
| United States | Medical Facility | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Iterum Therapeutics, International Limited |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success | Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen) | 12 +/- 1 day | |
| Primary | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success | Overall Success: 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) | Day 12+/-1 day | |
| Primary | Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success | Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen) | Day 12 +/- 1 day | |
| Secondary | Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success | Microbiologic success is defined as eradication of the baseline pathogen (<1000 Colony Forming Units (CFU)/mL) at the Test of Cure visit | Day 12+/-1 day |
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