Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06017479

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urological System Complication of Procedure Urinary Tract Infections	Drug: Fosfomycin 3000 MG Drug: Levofloxacin 500mg	Phase 1/Phase 2

Detailed Description

This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population is patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size in this study is 100 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p < 0.05.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 g and patients receiving levofloxacin 500 mg single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 g and patients receiving levofloxacin 500 mg single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.

Masking:

Single (Outcomes Assessor)

Masking Description:

This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 30, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-urodynamic Fosfomycin Fosfomycin 3 g single dosage 1 hour before the urodynamic examination	Drug: Fosfomycin 3000 MG Fosfomycin 3 g single dosage 1 hour before the urodynamic examination Other Names: Monuril
Experimental: Pre-urodynamic Levofloxacin Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination	Drug: Levofloxacin 500mg Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination Other Names: Levaquin

Arm

Intervention/Treatment

Experimental: Pre-urodynamic Fosfomycin

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Drug: Fosfomycin 3000 MG

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Other Names:

Monuril

Experimental: Pre-urodynamic Levofloxacin

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Drug: Levofloxacin 500mg

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Other Names:

Levaquin

Outcome Measures

Primary Outcome Measures

Number of Participant With Urinary Tract Infection [4 days post-urodynamic procedure]
Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocyes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male/female patients > 18 years who have indications for urodynamics
Willing to participate in research

Exclusion Criteria:

Allergy to levofloxacin
Allergy to fosfomycin
History of taking antibiotics in 1 month
Pregnant
Uncontrolled DM
Use of urinary catheter
Having a UTI before urodynamics, based on clinical symptoms and urine examination results
Refuse to participate in research