Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

• Sponsor: Omri Schwarztuch Gildor (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05577273
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.6
• Patients Per Site Per Month: 16.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases; Urinary Tract Disease	Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 arms: antibiotic prophylaxis vs no treatment2 arms: antibiotic prophylaxis vs no treatment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
• Actual Study Start Date: Aug 14, 2018
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/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
No Intervention: No treatment

Outcome Measures

Primary Outcome Measures

1. UTI [30 day]

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

Secondary Outcome Measures

1. positive culture approved UTI [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

2. Hospitalizations due to UTI [30 day]

3. Bacteremia [30 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• performing urological operation for other reason

Exclusion Criteria:

• cannot give informed consent

• <18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar-Sava		Israel

Sponsors and Collaborators

• Omri Schwarztuch Gildor

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• aua guidelines

Publications

None provided.

• Responsible Party: Omri Schwarztuch Gildor, Principal Investigator, Clalit Health Services
• ClinicalTrials.gov Identifier: NCT05577273
• Other Study ID Numbers: MMC-0048-18
• First Posted: Oct 13, 2022
• Last Update Posted: Oct 13, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Tract Infections; Urologic Diseases; Trimethoprim; Sulfamethoxazole; Penicillins; Cefuroxime; Cefuroxime axetil

Study Results

No Results Posted as of Oct 13, 2022