Renal StonePhase 3NCT05384197
Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients
A Phase 3 study testing Enhanced regimen and Extended regimen in people with Renal Stone, run by Mansoura University at 1 site in Egypt.
Trial summary
In the available literature, there is a lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- Enhanced regimen and Extended regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jul 2023
- Phase
- Phase 3
- 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
- Ability to give informed consent.
- Age ≥18 years.
- Renal stone <20 mm in which RIRS is recommended.
- High susceptibility of post-procedural infectious complications by one or more of the followings: - Positive preoperative urine culture within 12 weeks of the planned intervention. -Indwelling ureteral stents for more than 4 weeks. -Diabetes mellitus.
Who cannot join
- Solitary kidney.
- Chronic kidney disease.
- Pregnant.
- Have received antibiotics within 7 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Ehab Nour contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Urology and Nephrology Center
Al Mansurah, Outside U.S./Canada, 35516
Amr A Elsawy, 01009428750, amrelsawy.unc@hotmail.com
Ehab Nour, daehab1994@gmail.com
About this study
Official title: Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients: Randomized Controlled Trial
In the available literature, there is a lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Therefore this study is planning to investigate the optimal protocol for AP prior to RIRS in high-risk population through comparing the enhanced regimen (2days) vs. the extended regimen (7 days) in a randomized controlled trial (RCT).
Read the detailed description
Retrograde intrarenal surgery (RIRS) has gained a wide popularity in the management of renal stones due to tremendous technological advancements over the last years. According to the current guidelines, RIRS could be offered as a first line surgical treatment option for renal stones less than 20 mm (or ≤ 10 mm for lower pole stone/s) with favorable stone free rate (SFR).
Despite being a minimally invasive, several morbid complications could be encountered during/after RIRS. Post-operative infectious complications constitute one of the major reported complications after RIRS with varying presentations which include urosepsis, febrile urinary tract infection (UTI) and asymptomatic bacteriuria.
Several large-populations studies have reported the incidence of infectious complications post-RIRS. Among ≈ 12.000 patients undergoing ureteroscopy and were evaluated by The Clinical Research Office of Endourological Society (CROES), post-operative fever, UTI and urosepsis were reported in 1.8%, 1.3% and 0.3%, respectively. Moreover, in another report by Reducing Operative Complications from Kidney stones (ROCK) for 1.817 patients undergoing RIRS, 2.4% required hospital readmission (HR) for infectious complications.
The underlying mechanisms of infectious complications post-RIRS include combination of existing bacteria in the urinary tract and rising intrarenal pressure due to prolonged and/or vigorous irrigation. In addition, several studies have investigated the independent predictors of infectious complications after RIRS with identified positive preoperative urine culture or prior history of recurrent UTI, long-lasting indwelling ureteral stents, diabetes mellitus (DM) and immunocompromised patients.
In addition to the substantial patient morbidity, post-operative infectious complications constitute a major burden to the health care resources. Therefore, minimizing these devastating events should an important consideration by health care providers not only for improving the patient satisfaction but also for cost-saving issues. Therefore, it is a crucial entity for clinicians to identify high-risk patients for post-RIRS infectious complications and to exhaust the different clinical mitigations to minimize these events.
According to American Urological Association (AUA) Best Practice Statements on Antibiotic Prophylaxis (AP), single dose of perioperative antibiotics is indicated for all cases prior to RIRS. However, the exact regimen and duration of preoperative AP for high risk patients for infectious complication are still undefined.
In previous studies on AP for high risk patients prior to percutaneous nephrolithotomy (PCNL), different protocols were compared as regard to its impact on infectious events after PCNL. Despite the reported advantage of the extended regimen on minimizing the infectious events, the drawbacks of prolonged antibiotics as untoward adverse events (AEs) and drug resistance should be considered.
- Conditions
- Renal Stone
- Being tested
- Enhanced regimen, Extended regimen
- Keywords
- Renal stone, Retrograde intrarenal surgery, Infectious complications, Sepsis
- Medical subject headings
- Nephrolithiasis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced regimenDrug
Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days with the last day of AP course being one day prior to intervention.
In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily.
Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (2 days with the last day of AP course being one day prior to intervention)
Extended regimenDrug
Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 7 days with the last day of AP course being one day prior to intervention.
In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily.
Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (7 days with the last day of AP course being one day prior to intervention)
| Study group | Role | What they receive |
|---|---|---|
| Enhanced regimen | Active comparator | They will receive two days antibiotic prophylaxis according to the predetermined protocol.
Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days according to the assigned randomization group with the last day of AP course being one day prior to intervention.
In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily.
Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (2 days with the last day of AP course being one day prior to intervention) Receives: Drug: Enhanced regimen |
| Extended regimen | Active comparator | They will receive seven days antibiotic prophylaxis according to the predetermined protocol.
Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 7 days with the last day of AP course being one day prior to intervention.
In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily.
Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule ( 7 days with the last day of AP course being one day prior to intervention) Receives: Drug: Extended regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative sepsis
Postoperative sepsis is defined as severe post-procedural (within 12 hours after the procedure with coexisting positive urine culture) infectious complication with ≥ two of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure < 90 mmHg \& mean arterial pressure < 70 mmHg or systolic blood pressure decrease < 40 mmHg. - WBC >12,000 or <4,000.
Measured: 30 days after intervention
Secondary outcomes (2)
Rate of postoperative fever
Measured: 30 days after intervention
Rate of postoperative UTI
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the available literature, we lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Therefore we are planning to investigate the optimal protocol for AP prior to RIRS in high-risk population through comparing the enhanced regimen (2days) vs. the extended regimen (7 days) in a randomized controlled trial (RCT).
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Amr A Elsawy, Study director, Mansoura UniversityEhab Nour, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384197
- Sponsor's protocol ID
- AS-5-2022
- Status last verified
- Nov 2022
- First submitted
- 17 May 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsawy AA, Nour EA, Nabeeh A, El-Nahas AR. Enhanced versus extended preoperative antibiotic prophylaxis for retrograde intrarenal surgery in high infectious risk patients: a randomized controlled trial. World J Urol. 2025 Dec 29;44(1):70. doi: 10.1007/s00345-025-06150-x.
PubMed 41460253
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05384197
- Acronym / sponsor ID
- AS-5-2022
- Conditions
- Renal Stone
- Keywords
- Renal stone, Retrograde intrarenal surgery, Infectious complications, Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 May 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.
In the available literature, there is a lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Therefore this study is planning to investigate the optimal protocol for AP prior to RIRS in high-risk population through comparing the enhanced regimen (2days) vs. the extended regimen (7 days) in a randomized controlled trial (RCT).
Detailed description
Retrograde intrarenal surgery (RIRS) has gained a wide popularity in the management of renal stones due to tremendous technological advancements over the last years. According to the current guidelines, RIRS could be offered as a first line surgical treatment option for renal stones less than 20 mm (or ≤ 10 mm for lower pole stone/s) with favorable stone free rate (SFR).
Despite being a minimally invasive, several morbid complications could be encountered during/after RIRS. Post-operative infectious complications constitute one of the major reported complications after RIRS with varying presentations which include urosepsis, febrile urinary tract infection (UTI) and asymptomatic bacteriuria.
Several large-populations studies have reported the incidence of infectious complications post-RIRS. Among ≈ 12.000 patients undergoing ureteroscopy and were evaluated by The Clinical Research Office of Endourological Society (CROES), post-operative fever, UTI and urosepsis were reported in 1.8%, 1.3% and 0.3%, respectively. Moreover, in another report by Reducing Operative Complications from Kidney stones (ROCK) for 1.817 patients undergoing RIRS, 2.4% required hospital readmission (HR) for infectious complications.
The underlying mechanisms of infectious complications post-RIRS include combination of existing bacteria in the urinary tract and rising intrarenal pressure due to prolonged and/or vigorous irrigation. In addition, several studies have investigated the independent predictors of infectious complications after RIRS with identified positive preoperative urine culture or prior history of recurrent UTI, long-lasting indwelling ureteral stents, diabetes mellitus (DM) and immunocompromised patients.
In addition to the substantial patient morbidity, post-operative infectious complications constitute a major burden to the health care resources. Therefore, minimizing these devastating events should an important consideration by health care providers not only for improving the patient satisfaction but also for cost-saving issues. Therefore, it is a crucial entity for clinicians to identify high-risk patients for post-RIRS infectious complications and to exhaust the different clinical mitigations to minimize these events.
According to American Urological Association (AUA) Best Practice Statements on Antibiotic Prophylaxis (AP), single dose of perioperative antibiotics is indicated for all cases prior to RIRS. However, the exact regimen and duration of preoperative AP for high risk patients for infectious complication are still undefined.
In previous studies on AP for high risk patients prior to percutaneous nephrolithotomy (PCNL), different protocols were compared as regard to its impact on infectious events after PCNL. Despite the reported advantage of the extended regimen on minimizing the infectious events, the drawbacks of prolonged antibiotics as untoward adverse events (AEs) and drug resistance should be considered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the available literature, we lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Therefore we are planning to investigate the optimal protocol for AP prior to RIRS in high-risk population through comparing the enhanced regimen (2days) vs. the extended regimen (7 days) in a randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Enhanced regimen | Active comparator | Drug: Enhanced regimenThey will receive two days antibiotic prophylaxis according to the predetermined protocol. Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days according to the assigned randomization group with the last day of AP course being one day prior to intervention. In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily. Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (2 days with the last day of AP course being one day prior to intervention) |
| Extended regimen | Active comparator | Drug: Extended regimenThey will receive seven days antibiotic prophylaxis according to the predetermined protocol. Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 7 days with the last day of AP course being one day prior to intervention. In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily. Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule ( 7 days with the last day of AP course being one day prior to intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to give informed consent.
- Age ≥18 years.
- Renal stone <20 mm in which RIRS is recommended.
- High susceptibility of post-procedural infectious complications by one or more of the followings: - Positive preoperative urine culture within 12 weeks of the planned intervention. -Indwelling ureteral stents for more than 4 weeks. -Diabetes mellitus.
Key exclusion criteria (4 listed)
- Solitary kidney.
- Chronic kidney disease.
- Pregnant.
- Have received antibiotics within 7 days prior to enrollment.
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 |
|---|---|---|
| Enhanced regimenSulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days with the last day of AP course being one day prior to intervention. In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily. Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (2 days with the last day of AP course being one day prior to intervention) | Drug | Enhanced regimen |
| Extended regimenSulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 7 days with the last day of AP course being one day prior to intervention. In patients with allergy or resistance to TMP-SMX, the following antibiotics will be considered in the following order: 100 mg Nitrofurantoin twice daily, 500 mg Ciprofloxacin twice daily or 200 mg Cefpodoxime twice daily. Patients with positive culture which is sensitive only to parenteral antibiotics will receive culture-based intramuscular/intravenous antibiotics following the same schedule (7 days with the last day of AP course being one day prior to intervention) | Drug | Extended regimen |
Primary outcome
Rate of postoperative sepsis
Time frame: 30 days after intervention
Postoperative sepsis is defined as severe post-procedural (within 12 hours after the procedure with coexisting positive urine culture) infectious complication with ≥ two of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure < 90 mmHg \& mean arterial pressure < 70 mmHg or systolic blood pressure decrease < 40 mmHg. - WBC >12,000 or <4,000.
2 secondary outcomes
Rate of postoperative fever
Time frame: 30 days after intervention
Rate of postoperative UTI
Time frame: 30 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 41460253Elsawy AA, Nour EA, Nabeeh A, El-Nahas AR. Enhanced versus extended preoperative antibiotic prophylaxis for retrograde intrarenal surgery in high infectious risk patients: a randomized controlled trial. World J Urol. 2025 Dec 29;44(1):70. doi: 10.1007/s00345-025-06150-x.
- 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.
Ehab Nour contact
Amr A Elsawy study director
Mansoura University
Ehab Nour principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enhanced regimen and Extended regimen in people with Renal Stone, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 4 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 14 Nov 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Amr A Elsawy (01009428750, amrelsawy.unc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative sepsis (time frame: 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384197, which also lists 1 linked publication.
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 14 Nov 2022.