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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017479
• Other study ID #: 22-11-1343
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 30, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections
• Urological System Complication of Procedure

Intervention

Drug:
• Fosfomycin 3000 MG
Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
• Levofloxacin 500mg
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 : leukocytes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase	4 days post-urodynamic procedure