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Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Primary Purpose

Urologic Diseases, Urinary Tract Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)
Sponsored by
Omri Schwarztuch Gildor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • performing urological operation for other reason

Exclusion Criteria:

  • cannot give informed consent
  • <18 years

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibiotic prophylaxis

No treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

UTI
Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms

Secondary Outcome Measures

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
Hospitalizations due to UTI
Bacteremia
Number of patients admitted to the hospital, that have at least 1 positive blood culture

Full Information

First Posted
October 5, 2022
Last Updated
October 9, 2022
Sponsor
Omri Schwarztuch Gildor
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1. Study Identification

Unique Protocol Identification Number
NCT05577273
Brief Title
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
Official Title
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omri Schwarztuch Gildor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Urinary Tract Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arms: antibiotic prophylaxis vs no treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic prophylaxis
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)
Intervention Description
single dose of P.O. Cefuroxime Axetil 500 mg. For penicillin allergy patients, single dose of P.O. Trimethoprim/Sulfamethoxazole 160mg/800mg
Primary Outcome Measure Information:
Title
UTI
Description
Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms
Time Frame
30 day
Secondary Outcome Measure Information:
Title
positive culture approved UTI
Description
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
Time Frame
30 day
Title
Hospitalizations due to UTI
Time Frame
30 day
Title
Bacteremia
Description
Number of patients admitted to the hospital, that have at least 1 positive blood culture
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: performing urological operation for other reason Exclusion Criteria: cannot give informed consent <18 years
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Sava
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.auanet.org/documents/education/clinical-guidance/Antimicrobial-Prophylaxis.pdf
Description
aua guidelines

Learn more about this trial

Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

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