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NCT05577273 Clinical Trial

Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Urologic Diseases Clinical Trial

Official title:
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05577273
Other study ID # MMC-0048-18
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 14, 2018
Est. completion date August 31, 2023

Study information
Verified date October 2022
Source Clalit Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

At the end of most urological procedures, the doctor inserts a urethral catheter for a period of up to 5 days. According to AUA's guidelines, prophylactic antibiotic is indicated during catheter removal. The aim of our study is to check the influence of the antibiotic treatment on urinary tract infections after catheter removal

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - performing urological operation for other reason Exclusion Criteria: - cannot give informed consent - <18 years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)
single dose of P.O. Cefuroxime Axetil 500 mg. For penicillin allergy patients, single dose of P.O. Trimethoprim/Sulfamethoxazole 160mg/800mg

Locations
Country Name City State
Israel Meir Medical Center Kfar-Sava

Sponsors (1)
Lead Sponsor Collaborator
Omri Schwarztuch Gildor

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary UTI Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms 30 day
Secondary positive culture approved UTI Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms, and a positive urine/blood culture taken during the time frame 30 day
Secondary Hospitalizations due to UTI 30 day
Secondary Bacteremia Number of patients admitted to the hospital, that have at least 1 positive blood culture 30 day
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