CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Fosfomycin 3000 MG +1 moredrug
Likely dose
Fosfomycin 3000 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06017479
NCT06017479Phase 2Completed

Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination

Indonesia University·interventional·Posted Aug 30, 2023·Updated Oct 9, 2024

In Brief

A Phase 2 clinical trial evaluating Fosfomycin 3000 MG and Levofloxacin 500mg for Urological System Complication of Procedure and Urinary Tract Infections. Completed, enrolled 126 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question\[s\] it aims to answer are: * What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination? * What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 30, 2023
Enrollment StartDec 30, 2022
Primary CompletionMar 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.8 years ago

Interventions

Fosfomycin 3000 MGdrug

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Levofloxacin 500mgdrug

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination