Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT05584657
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05584657
Study Brief:
Protocol Section:
NCT05584657