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

NCT06017479 | Completed Phase 1 Results

• 1 other identifier: 22-11-1343
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Urological System Complication of Procedure; Urinary Tract Infections

Keywords

urodynamic; urinary tract infections; fosfomycin; levofloxacin

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Pre-urodynamic Fosfomycin

EXPERIMENTAL

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Drug: Fosfomycin 3000 MG

Pre-urodynamic Levofloxacin

EXPERIMENTAL

Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination

Drug: Levofloxacin 500mg

Interventions

Fosfomycin 3000 MG DRUG

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Also known as: Monuril

Pre-urodynamic Fosfomycin

Levofloxacin 500mg DRUG

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Also known as: Levaquin

Pre-urodynamic Levofloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (3)

• Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90.

  PMID: 27550876 BACKGROUND

• Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2.

  PMID: 29305250 BACKGROUND

• Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511.

  PMID: 32823650 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fosfomycin; Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The limitation of the study is that many of the patients with UTIs refuse to undergo urine culture tests due to several reasons.

Results Point of Contact

• Title: Prof. dr. Harrina Erlianti Rahardjo, Sp.U(K), PhD
• Organization: Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital

harrinaerlianti@gmail.com

+62 816-825-226

Study Officials

• Harrina E Rahardjo, Professor

  Indonesia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 grams and patients receiving levofloxacin 500 miligrams single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: December 30, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date
• Access Criteria: Anyone who wishes to access the data

Locations

ID (1)