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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04575493
Eligibility Criteria:
Inclusion Criteria:
* Age 15 to 60 years with symptomatic acute urinary tract infection.
* Willing to participate in the study
* Non-pregnant adult females.
* Clinical signs and symptoms of a UTI (e.g., dysuria, frequency, urgency to urinate, Burning sensations during urination, Hematuria, suprapubic pain) with onset of symptoms \< 72 hours prior to study entry.
* One positive pre-treatment clean-catch midstream urine culture within 48 hours of enrollment in the study, defined as \> 105 CFU/mL.
* Patients having all socioeconomic classes including lower, middle and higher.
* In-vitro susceptibility testing of the uropathogen to test and control drug.
Exclusion Criteria:
* • Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control. If an antimicrobial agent is to be studied for the treatment of UTI in pregnant women, this proposal should be justified, the risk/benefit expectations explained, and the issue presented to the division.
* Three or more episodes of acute uncomplicated UTI in the past 12 months.
* Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder.
* Patients with onset of symptoms 96 hours or more prior to entry.
* Patients with a temperature \> 1010 F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection.
* Patients with known or suspected hypersensitivity to the test or control drug.
* Patients who received treatment with other antimicrobials within 48 hours prior to entry.
* Patient suffering in chronic illness Diabetes mellitus, chronic liver diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
60 Years
Study:
NCT04575493
Study Brief:
Protocol Section:
NCT04575493