Status:
COMPLETED
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
Lead Sponsor:
Iterum Therapeutics, International Limited
Conditions:
Uncomplicated Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
- Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
- A mid-stream urine specimen with:
- a dipstick analysis positive for nitrite AND
- 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
- Has given written informed consent to participate in the study.
Exclusion
- Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
- Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
- Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
- Patients with ileal loops or urinary stoma
- Patients with an indwelling urinary catheter in the previous 30 days
- Patients with paraplegia
- Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
- Any history of trauma to the pelvis or urinary tract
- 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
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- Known history of creatinine clearance \<50 mL/min
- Patients known to have liver disease
- Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
- Patients with uncontrolled diabetes mellitus
- Patients with history of blood dyscrasias
- Patients with history of uric acid kidney stones
- Patients with acute gouty attack
- Patients on chronic methotrexate therapy
- Patient known to be immunocompromised
- Patients with a known history of myasthenia gravis
- Patients who require concomitant administration of tizanidine or valproic acid
- Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid
- 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
- History of seizures
- Use of any other investigational drug in the 30 days prior to the study
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2020
Estimated Enrollment :
1671 Patients enrolled
Trial Details
Trial ID
NCT03354598
Start Date
August 1 2018
End Date
January 20 2020
Last Update
January 12 2021
Active Locations (60)
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1
Medical Facility
Birmingham, Alabama, United States, 35242
2
Medical Facility
Phoenix, Arizona, United States, 85032
3
Medical Facility
Tolleson, Arizona, United States, 85353
4
Medical Facility
Cerritos, California, United States, 90703