Urologic DiseasesNCT05577273
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
A study testing Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy) in people with Urologic Diseases and Urinary Tract Disease, run by Omri Schwarztuch Gildor at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Urinary Tract Disease
- What is being tested?
- Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Aug 2018to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- performing urological operation for other reason
Who cannot join
- cannot give informed consent
- <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Urologic Diseases, Urinary Tract Disease
- Being tested
- Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy) |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
UTI
Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms
Measured: 30 day
Secondary outcomes (3)
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
Measured: 30 day
Hospitalizations due to UTI
Measured: 30 day
Bacteremia
Number of patients admitted to the hospital, that have at least 1 positive blood culture
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start14 Aug 2018
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms: antibiotic prophylaxis vs no treatment
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omri Schwarztuch Gildor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omri Schwarztuch Gildor, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577273
- Sponsor's protocol ID
- MMC-0048-18
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT05577273
- Acronym / sponsor ID
- MMC-0048-18
- Conditions
- Urologic Diseases, Urinary Tract Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Omri Schwarztuch GildorUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms: antibiotic prophylaxis vs no treatment
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis | Experimental | Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)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. |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- performing urological operation for other reason
Key exclusion criteria (2 listed)
- cannot give informed consent
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Antibiotic prophylaxis |
Primary outcome
UTI
Time frame: 30 day
Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms
3 secondary outcomes
positive culture approved UTI
Time frame: 30 day
Hospitalizations due to UTI
Time frame: 30 day
Bacteremia
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy) in people with Urologic Diseases and Urinary Tract Disease, run by Omri Schwarztuch Gildor at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UTI (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.