Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Completed · Phase 3
Conditions studied: Urinary Tract Infections, Cystitis
In brief
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
Key facts
- Study ID
- NCT05584657
- Run by
- Iterum Therapeutics, International Limited
- People needed
- 2229
- Starts
- 2022-10-18
- Expected to finish
- 2023-11-21
- Last updated by the study team
- 2024-11-20
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 hours and ≤96 hours of urinary symptoms attributable to a UTI
- Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
- A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine
You may not qualify if…
- Presence of signs and symptoms suggestive of acute pyelonephritis defined as: 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, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
- Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
- Ongoing urinary retention
- Neurogenic bladder
- Current resident of a long-term care facility
- Instrumentation of urinary tract in the previous 30 days
- An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
- Any history of trauma to the pelvis or urinary tract
- Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
- History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
Where it is running
- Medical Facility — Miami Beach, Florida, United States
- Medical Facility — Miami Gardens, Florida, United States
- Medical Facility2 — Miami Lakes, Florida, United States
- Medical Facility — Miami Lakes, Florida, United States
- Medical Facility — Orlando, Florida, United States
- Medical Facility2 — Orlando, Florida, United States
- Medical Facility — Ormond Beach, Florida, United States
- Medical Facility — Pompano Beach, Florida, United States
- Medical Facility — Eugene, Oregon, United States
- Medical Facility — Portland, Oregon, United States
- Medical Facility — Beaver, Pennsylvania, United States
- Medical Facility — Scottdale, Pennsylvania, United States
- Medical Facility — Smithfield, Pennsylvania, United States
- Medical Facility — Upper Saint Clair, Pennsylvania, United States
- Medical Facility — Cullman, Alabama, United States
- Medical Facility — Saraland, Alabama, United States
- Medical Facility — Sheffield, Alabama, United States
- Medical Facility — Peoria, Arizona, United States
- Medical Facility3 — Phoenix, Arizona, United States
- Medical Facility — Phoenix, Arizona, United States
- Medical Facility2 — Phoenix, Arizona, United States
- Medical Facility — Tucson, Arizona, United States
- Medical Facility2 — Hot Springs, Arkansas, United States
- Medical Facility — Hot Springs, Arkansas, United States
- Medical Facility4 — Miami, Florida, United States
Full record on ClinicalTrials.gov
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