Urinary Tract InfectionsNCT04731090
Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
A study testing IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. and Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths in people with Urinary Tract Infections, run by Egyptian Biomedical Research Network at 1 site in Saudi Arabia.
Trial summary
Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. and Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2018to 30 Sep 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.
Who cannot join
- Symptomatic urinary tract infection.
- Use of rigid ureteroscopy and antegrade ureteroscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Standard Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures.
Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
- Conditions
- Urinary Tract Infections
- Being tested
- IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively., Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.Drug
IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheathsOther
Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
| Study group | Role | What they receive |
|---|---|---|
| Standard antibiotic prophylaxis | Active comparator | IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. Receives: Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. |
| enhanced prophylaxis | Experimental | Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used. Receives: Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection
Postoperative UTI was defined as the occurrence of a temperature higher than 38 °C associated with pyuria and/or bacteriuria without any other focal infectious sites.
Measured: 30-day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Aug 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mohamed Elhelaly, Principal investigator, Al-Azhar Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731090
- Sponsor's protocol ID
- N2113
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 29 Jan 2021
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standard Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
- ClinicalTrials.gov ID
- NCT04731090
- Acronym / sponsor ID
- N2113
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Jan 2021 (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.
Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures.
Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard antibiotic prophylaxis | Active comparator | Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. |
| enhanced prophylaxis | Experimental | Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheathsPatients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.
Key exclusion criteria (2 listed)
- Symptomatic urinary tract infection.
- Use of rigid ureteroscopy and antegrade ureteroscopy.
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 |
|---|---|---|
| IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. | Drug | Standard antibiotic prophylaxis |
| Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheathsPatients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used. | Other | enhanced prophylaxis |
Primary outcome
Urinary tract infection
Time frame: 30-day postoperative
Postoperative UTI was defined as the occurrence of a temperature higher than 38 °C associated with pyuria and/or bacteriuria without any other focal infectious sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- 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.
Mohamed Elhelaly principal investigator
Al-Azhar Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. and Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths in people with Urinary Tract Infections, run by Egyptian Biomedical Research Network at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 29 Jan 2021. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary tract infection (time frame: 30-day postoperative). 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 29 Jan 2021.