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NCT02424461: PROSTASHORT

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

Completed Phase 3 Last updated 1 May 2024
What this trial tests

Phase 3 trial testing Ceftriaxone in Acute Male Urinary Tract Infection in 274 participants. Completed in 25 July 2019.

Timeline
25 January 2015
Primary endpoint
25 February 2019
25 July 2019

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment274
Start date25 January 2015
Primary completion25 February 2019
Estimated completion25 July 2019
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, male only, with Acute Male Urinary Tract Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
    Lafaurie M, Chevret S, Fontaine JP, Mongiat-Artus P, et al · · 2023 · cited 22× · PMID 36785526 · DOI 10.1093/cid/ciad070

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Other Assistance Publique - Hôpitaux de Paris trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02424461.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing