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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354598
Other study ID # IT001-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1, 2018
Est. completion date January 20, 2020

Study information

Verified date December 2019
Source Iterum Therapeutics, International Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sulopenem-Etzadroxil/Probenecid
Treatment of uncomplicated urinary tract infection
Ciprofloxacin
Treatment of uncomplicated urinary tract infection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Iterum Therapeutics, International Limited

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Suspended NCT05138822 - Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections Phase 1
Completed NCT01650051 - Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI) Phase 3