Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

Completed · Phase 3

Conditions studied: Uncomplicated Urinary Tract Infections

In brief

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

Key facts

Study ID

NCT03354598

Run by

Iterum Therapeutics, International Limited

People needed

1671

Starts

2018-08-01

Expected to finish

2020-01-20

Last updated by the study team

2021-01-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Medical Facility — Los Angeles, California, United States
• Medical Facility — 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
• Medical Facility — 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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