Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02424461
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2015-03-06
Brief Title:
Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTASHORT
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM12268 | OTHER_GRANT | France Ministry of Health PHRC | None |