Acute Male Urinary Tract Infection Clinical Trial
— PROSTASHORTOfficial title:
Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection Due to Fluoroquinolones Susceptible Bacteria: a Multicentre, Non-inferiority, Double Blind, Randomized Placebo-controlled Trial
| Verified date | April 2024 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 274 |
| Est. completion date | July 25, 2019 |
| Est. primary completion date | February 25, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Saint Louis hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success defined by resolution of fever | Defined by 3 criteria that should be fulfilled:
resolution of fever between the end of treatment and 4 weeks thereafter (except fever not related to urine infection), sterile urine (except alpha-hemolytic streptococus, Lactobacillus, Corynebacterium, Gardnerella or coagulase negative Staphylococcus) analysis 4 weeks after completion of antimicrobial therapy, and no antibiotic therapy active against the bacterial strain responsible for the UTI within the 4 week period following antimicrobial therapy |
day 42 | |
| Secondary | Intestinal carriage of antimicrobial-resistant Gram-negative bacilli | intestinal carriage of antimicrobial-resistant Gram-negative bacilli at the end of treatment and 4 and 12 weeks after completing study medication, as compared to a baseline sample taken before treatment | 4 and 12 weeks | |
| Secondary | Incidence and severity of adverse drug events | the incidence and severity of adverse drug events within the treatment period and in the 4 and 12 weeks after completing study medication | 4 and 12 weeks | |
| Secondary | Recurrent UTI | Recurrent UTI within 4 weeks and 12 weeks of completing active study medication | 4 and 12 weeks |