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

NCT02424461 | Completed Phase 3

• 2 other identifiers: P120116AOM12268
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Male Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Success defined by resolution of fever

  Defined by 3 criteria that should be fulfilled: 1. resolution of fever between the end of treatment and 4 weeks thereafter (except fever not related to urine infection), 2. sterile urine (except alpha-hemolytic streptococus, Lactobacillus, Corynebacterium, Gardnerella or coagulase negative Staphylococcus) analysis 4 weeks after completion of antimicrobial therapy, and 3. no antibiotic therapy active against the bacterial strain responsible for the UTI within the 4 week period following antimicrobial therapy

  day 42

Secondary Outcomes (3)

• Intestinal carriage of antimicrobial-resistant Gram-negative bacilli

  4 and 12 weeks

• Incidence and severity of adverse drug events

  4 and 12 weeks

• Recurrent UTI

  4 and 12 weeks

Study Arms (2)

7 day-antimicrobial treatment

ACTIVE COMPARATOR

Ceftriaxone : 1 injection 1 g per day for 2 days Ofloxacine : 400 mg/jour (200 mg/ jour in case of renal failure) for seven days Placebo of ofloxacine for 7 days

Drug: Ceftriaxone; Drug: Ofloxacine

14-day antimicrobial treatment

ACTIVE COMPARATOR

Ceftriaxone : 1 injection 1 g per day for 2 days Ofloxacine : 400 mg/jour (200 mg/ jour in case of renal failure) for 14 days

Drug: Ceftriaxone; Drug: Ofloxacine; Drug: Placebo of ofloxacine

Interventions

Ceftriaxone DRUG

1 injection 1 g per day for 2 days

14-day antimicrobial treatment; 7 day-antimicrobial treatment

Ofloxacine DRUG

400 mg/jour (200 mg/ jour in case of renal failure) for seven days

14-day antimicrobial treatment; 7 day-antimicrobial treatment

Placebo of ofloxacine DRUG

Placebo of ofloxacine for 7 days

14-day antimicrobial treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male gender, 18 years and older
• New-onset of the following criteria:
• Temperature ≥38° Celsius or \<36° Celsius (or at least once in the 3 previous days), AND
• 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).

You may not qualify if:

• 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))

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis hospital

Paris, 75010, France

Location

Related Publications (1)

• Lafaurie M, Chevret S, Fontaine JP, Mongiat-Artus P, de Lastours V, Escaut L, Jaureguiberry S, Bernard L, Bruyere F, Gatey C, Abgrall S, Ferreyra M, Aumaitre H, Aparicio C, Garrait V, Meyssonnier V, Bourgarit-Durand A, Chabrol A, Piet E, Talarmin JP, Morrier M, Canoui E, Charlier C, Etienne M, Pacanowski J, Grall N, Desseaux K, Empana-Barat F, Madeleine I, Bercot B, Molina JM, Lefort A; PROSTASHORT Study Group. Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Clin Infect Dis. 2023 Jun 16;76(12):2154-2162. doi: 10.1093/cid/ciad070.

  PMID: 36785526 BACKGROUND

MeSH Terms

Interventions

Ceftriaxone; Ofloxacin

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: April 23, 2015
• Study Start: January 25, 2015
• Primary Completion: February 25, 2019
• Study Completion: July 25, 2019
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

FR (1)