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

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ClinicalTrials.gov Identifier: NCT02424461
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Acute Male Urinary Tract Infection Drug: Ceftriaxone Drug: Ofloxacine Drug: Placebo of ofloxacine Phase 3

Detailed Description:

The proposed study is a multicentre, non-inferiority, double blind, randomized placebo-controlled trial of treatment duration for male urinary tract infection (UTI) due to fluoroquinolones susceptible bacteria. Specifically, 284 men with a UTI will be randomized to 7 vs. 14 days of antimicrobial treatment. The primary outcome is resolution of fever, sterile urine 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. Secondary outcomes include the intestinal carriage of antimicrobial-resistant Gram-negative bacilli at the end of treatment, the incidence and severity of adverse drug events and the recurrent UTI within the treatment period and 4 weeks and 12 weeks of completing active study medication.

Currently, the optimal treatment duration for male UTI is unknown. Only one randomized study showed no difference in outcomes, in patients treated with ciprofloxacin during 14 vs. 28 days. However, this study was underpowered and included patient in a single center. Current treatment guidelines are not consensual and recommend treating men with UTI for 7 to 4 or 6 weeks. Shorter durations may expose patients to recurrence when longer duration may be associated with increase in Clostridium difficile infection and antimicrobial resistance. Longer-duration treatment is also more costly and inconvenient to patients. Thus, since longer-duration treatment is associated with some adverse outcomes, in order to justify longer-duration treatment thee must be some clinically significant benefit to the extended treatment.

The proposed randomized placebo-controlled trial will test the hypothesis that 7 days of antimicrobial treatment is non-inferior for the resolution of fever and microbiological success when compared to 14 days of treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ofloxacin

Arm Intervention/treatment
Active Comparator: 7 day-antibiomicrobial treatment

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
1 injection 1 g per day for 2 days

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

Drug: Ofloxacine
400 mg/jour (200 mg/ jour in case of renal failure) for 14 days

Active Comparator: 14-day antibiomicrobial treatment

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
1 injection 1 g per day for 2 days

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

Drug: Placebo of ofloxacine
Placebo of ofloxacine for 7 days




Primary Outcome Measures :
  1. Success defined by resolution of fever [ Time Frame: day 42 ]
    Defined by resolution of fever, sterile urine 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


Secondary Outcome Measures :
  1. Intestinal carriage of antimicrobial-resistant Gram-negative bacilli [ Time Frame: 4 and 12 weeks ]
    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

  2. Incidence and severity of adverse drug events [ Time Frame: 4 and 12 weeks ]
    the incidence and severity of adverse drug events within the treatment period and in the 4 and 12 weeks after completing study medication

  3. Recurrent UTI [ Time Frame: 4 and 12 weeks ]
    Recurrent UTI within 4 weeks and 12 weeks of completing active study medication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424461


Contacts
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Contact: Matthieu LAFAURIE, MD +33 1 42 02 66 45 matthieu.lafaurie@sls.ap-hop-paris.fr

Locations
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France
Saint Louis hospital Recruiting
Paris, France, 75010
Contact: Matthieu Lafaurie, MD    +33 1 42 02 66 45    matthieu.lafaurie@sls.ap-hop-paris.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02424461     History of Changes
Other Study ID Numbers: P120116
AOM12268 ( Other Grant/Funding Number: France: Ministry of Health (PHRC) )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Anti-Infective Agents, Urinary
Urologic Diseases
Anti-Bacterial Agents
Ceftriaxone
Ofloxacin
Levofloxacin
Anti-Infective Agents
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors