Clinical trial

Comparison of the Effectiveness of Preurodynamic Single Dose of Levofloxacin With Posturodynamic Levofloxacin for Three Days on the Incidence of Urinary Tract Infections

Name
341/UN2.F1/ETIK/PPM.00.02/2021
Description
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.
Trial arms
Trial start
2022-02-04
Estimated PCD
2022-04-03
Trial end
2022-04-13
Status
Completed
Phase
Early phase I
Treatment
Pre-urodynamic Levofloxacin
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
Arms:
Pre-urodynamic Levofloxacin
Post-urodynamic Levofloxacin
Administering once daily Levofloxacin 500 mg for 3 days after urodynamic study
Arms:
Post-urodynamic Levofloxacin
Size
134
Primary endpoint
Number of Participant With Urinary Tract Infection
4 days after urodynamic
Eligibility criteria
Inclusion Criteria: * Male/female patients \> 18 years who have indications for urodynamics * Willing to participate in research Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ACTUAL'}}
Updated at
2023-11-13

1 organization

2 products

1 indication