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

October 2, 2024 updated by: dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD, Indonesia University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 consists of patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size required for this study is 126 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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 miligrams 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Main Outcome Measure Was the Incidence of Urinary Tract Infection (UTI) Post-urodynamic Study (UDS), Diagnosed Through Urinalysis Indicating Leukocyturia, Positive Bacteria, Nitrite, and/or Leukocyte Esterase, Along With Clinical Symptoms.
Time Frame: 4 days post-urodynamic procedure
Urinary tract infections (UTIs) were diagnosed using a combination of urinalysis and clinical symptoms. A positive result was determined by leukocyturia (more than five white blood cells per field of vision), presence of bacteria, nitrite, and/or leukocyte esterase. Patients diagnosed with UTI underwent urine cultures to identify bacterial presence and determine the specific pathogen. The study used descriptive statistics to compare UTI incidences between the two treatment groups (levofloxacin vs. fosfomycin), and statistical significance was assessed using chi-square analysis with a p-value of <0.05.
4 days post-urodynamic procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Harrina E Rahardjo, Professor, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2022

Primary Completion (Actual)

March 25, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-11-1343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

These are the study protocol used in this study

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

Anyone who wishes to access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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