Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

October 9, 2022 updated by: Omri Schwarztuch Gildor

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Sava, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • performing urological operation for other reason

Exclusion Criteria:

  • cannot give informed consent
  • <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
Experimental: Antibiotic prophylaxis
Single dose of p.o. antibiotic given 1 hour before catheter removal. The antibiotic of choice is Cefuroxime axetil 500 mg. For penicillin allergy, trimethoprim/sulfamethoxazole 160mg/800mg.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UTI
Time Frame: 30 day
Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms
30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive culture approved UTI
Time Frame: 30 day
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
Hospitalizations due to UTI
Time Frame: 30 day
30 day
Bacteremia
Time Frame: 30 day
Number of patients admitted to the hospital, that have at least 1 positive blood culture
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omri Schwarztuch Gildor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 9, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-0048-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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