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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT00598403
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant adult females (\>= 18)
* Clinical signs and symptoms of uncomplicated acute cystitis (dysuria, urgency, frequency, suprapubic pain) with symptoms starting \<=72 hours prior the study entry
* Positive pre-treatment clean-catch midstream urine culture (\>= 103 CFU/ml) and pyuria (10 leukocytes/mm3 or more than 5 leukocytes/field 40x magnification) within the 48 hours prior to inclusion in the study
* In vitro susceptibility testing of the isolated uropathogen to the drugs under study
* Written informed consent
Exclusion Criteria:
* Males
* Woman who are pregnant, nursing or not using a medically accepted, effective method of birth control
* Three or more episodes of uncomplicated acute infections of the urinary tract during the past 12 months
* Symptoms starting \>4 days prior to admission
* Body temperature \>= 38.3ºC, back pain, chills or other manifestations suggestive of upper urinary infection
* Evidence of structural or functional alterations of the urinary tract, such as calculi, stenosis, primary renal disease (eg. polycystic renal disease) or neurogenic bladder
* Underlying disease predisposing to complicated urinary tract infections such as diabetes mellitus, immunosuppression, leucopenia, heart insufficiency, liver impairment and neoplastic processes
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00598403
Study Brief:
Protocol Section:
NCT00598403