Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will investigate the treatment of urinary tract infection (UTI) in men. The investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior to a longer duration of antibiotics (14 days). The investigators will also study whether longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota or an increase in drug side effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Ceftriaxone; Levofloxacin; Ofloxacin

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