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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02424461
Eligibility Criteria:
Inclusion Criteria:
* Male gender, 18 years and older
* New-onset of the following criteria:
1. Temperature ≥38° Celsius or \<36° Celsius (or at least once in the 3 previous days), AND
2. at least one of following symptoms/findings: dysuria, urinary frequency, urgency, urinary burning, hematuria, perineal pain, supra-pubic pain or urinary retention, painful prostate (digital prostate examination)
* Leucocyturia ≥ 10/ mm3
* Urinary signs/symptoms within the 3 previous months
* Urinary culture yielding a single pathogen, at least10\^3 colony-forming unit (CFU)/ml, susceptible to nalidixic acid, ofloxacine and ceftriaxone.
* Oral route for study drug
* Normal Ultrasound prostatic findings (no abscess and post-void residual urine volume \< 100 ml).
Exclusion Criteria:
* Septic shock
* Admission to the hospital (for \> 48 h) at the time of diagnosis
* Treatment for UTI in the past year
* Urinary catheter
* Severe disease with strong probability of death within 3 months
* Severe allergy or contraindication to fluoroquinolones or beta-lactams
* Not able to give informed consent
* Antimicrobial therapy with fluoroquinolone or aminoglycoside in the 3 previous days
* Neutropenia (neutrophils count \< 500/mm3)
* Renal insufficiency (creatinin clearance ≤ 20 ml/min)
* Glucose - 6 - Phosphate - Dehydrogenase deficiency
* Significant cognitive disorders
* Uncontrolled epilepsy
* History of tendinitis
* Elevated liver enzyme levels (aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) ≥ 5 upper limit of normal range (ULN))
* Myasthenia
* Significant psychiatric disorders
* Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Patient under guardianship patient, guardianship or without social security cover
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02424461
Study Brief:
Protocol Section:
NCT02424461