NCT05577273

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

October 5, 2022

Last Update Submit

October 9, 2022

Conditions

Urologic DiseasesUrinary Tract Disease

Outcome Measures

Primary Outcomes (1)

  • UTI

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

    30 day

Secondary Outcomes (3)

  • positive culture approved UTI

    30 day

  • Hospitalizations due to UTI

    30 day

  • Bacteremia

    30 day

Study Arms (2)

Antibiotic prophylaxis

EXPERIMENTAL

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)

No treatment

NO INTERVENTION

Interventions

Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)DRUG

single dose of P.O. Cefuroxime Axetil 500 mg. For penicillin allergy patients, single dose of P.O. Trimethoprim/Sulfamethoxazole 160mg/800mg

Antibiotic prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • performing urological operation for other reason

You may not qualify if:

  • cannot give informed consent
  • \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Urologic Diseases

Interventions

cefuroxime axetilTrimethoprim

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 arms: antibiotic prophylaxis vs no treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 13, 2022

Study Start

August 14, 2018

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)