AzTrials
AzTrials

Acute Male Urinary Tract InfectionPhase 3PROSTASHORTNCT02424461

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

A Phase 3 study testing Ceftriaxone and Ofloxacine in people with Acute Male Urinary Tract Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Acute Male Urinary Tract Infection
What is being tested?
Ceftriaxone and Ofloxacine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
1 siteFrance
Study dates
25 Jan 2015to 25 Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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).

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Saint Louis hospital

    Paris, 75010

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Ceftriaxone, Ofloxacine, Placebo of ofloxacine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeftriaxoneDrug

    1 injection 1 g per day for 2 days

  • OfloxacineDrug

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

  • OfloxacineDrug

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

  • Placebo of ofloxacineDrug

    Placebo of ofloxacine for 7 days

Study groups in NCT02424461
Study groupRoleWhat they receive
7 day-antimicrobial treatmentActive comparatorCeftriaxone : 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
Receives: Drug: Ceftriaxone; Drug: Ofloxacine
14-day antimicrobial treatmentActive comparatorCeftriaxone : 1 injection 1 g per day for 2 days Ofloxacine : 400 mg/jour (200 mg/ jour in case of renal failure) for 14 days
Receives: Drug: Ceftriaxone; Drug: Ofloxacine; Drug: Placebo of ofloxacine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: day 42

Secondary outcomes (3)

  1. 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

    Measured: 4 and 12 weeks

  2. 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

    Measured: 4 and 12 weeks

  3. Recurrent UTI

    Recurrent UTI within 4 weeks and 12 weeks of completing active study medication

    Measured: 4 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study start25 Jan 2015
  3. Primary completion25 Feb 2019
  4. Study completion25 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424461
Sponsor's protocol ID
P120116
Other IDs
AOM12268
Acronym
PROSTASHORT
Status last verified
Apr 2024
First submitted
6 Mar 2015
Last updated
1 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36785526

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ceftriaxone and Ofloxacine in people with Acute Male Urinary Tract Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success defined by resolution of fever (time frame: day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in