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Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients

Primary Purpose

Renal Stone

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Enhanced regimen
Extended regimen
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Stone focused on measuring Renal stone, Retrograde intrarenal surgery, Infectious complications, Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Solitary kidney.
  • Chronic kidney disease.
  • Pregnant.
  • Have received antibiotics within 7 days prior to enrollment.

Sites / Locations

  • Mansoura Urology and Nephrology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enhanced regimen

Extended regimen

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of postoperative fever
Rate of postoperative UTI

Full Information

First Posted
May 17, 2022
Last Updated
November 8, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05384197
Brief Title
Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients
Official Title
Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
Keywords
Renal stone, Retrograde intrarenal surgery, Infectious complications, Sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced regimen
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Extended regimen
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Enhanced regimen
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Extended regimen
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of postoperative sepsis
Description
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.
Time Frame
30 days after intervention
Secondary Outcome Measure Information:
Title
Rate of postoperative fever
Time Frame
30 days after intervention
Title
Rate of postoperative UTI
Time Frame
30 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Solitary kidney. Chronic kidney disease. Pregnant. Have received antibiotics within 7 days prior to enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A Elsawy
Phone
01009428750
Email
amrelsawy.unc@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab Nour
Email
daehab1994@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Elsawy
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ehab Nour
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura Urology and Nephrology Center
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr A Elsawy
Phone
01009428750
Email
amrelsawy.unc@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ehab Nour
Email
daehab1994@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients

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