Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

NCT05219877 | Completed Phase 1 Results DMC

• 1 other identifier: 341/UN2.F1/ETIK/PPM.00.02/2021
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.

Conditions

Urinary Tract Infections

Keywords

Urodynamics; Antibiotics; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of Participant With Urinary Tract Infection

  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

  4 days after urodynamic

Study Arms (2)

Pre-urodynamic Levofloxacin

EXPERIMENTAL

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Drug: Pre-urodynamic Levofloxacin

Post-urodynamic Levofloxacin

ACTIVE COMPARATOR

Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination

Drug: Post-urodynamic Levofloxacin

Interventions

Pre-urodynamic Levofloxacin DRUG

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Pre-urodynamic Levofloxacin

Post-urodynamic Levofloxacin DRUG

Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study

Post-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
• History of taking antibiotics in 1 month • Pregnant
• Uncontrolled DM
• Use a 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)

RS Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

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
• Organization: Department of Urology, Faculty of Medicine University of Indonesia - Cipto Mangunkusumo General Hospital

harrinaerlianti@gmail.com

+62 816-825-226

Study Officials

• Harrina Erlianti 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: Prof. dr., Sp.U(K), PhD

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 levofloxacin 500 mg single dose one hour before urodynamic examination and patients receiving levofloxacin 500 mg once daily for three days post-urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 2, 2022
• Study Start: February 4, 2022
• Primary Completion: April 3, 2022
• Study Completion: April 13, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-02

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)