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

NCT05384197 | Unknown Phase 3

• 1 other identifier: AS-5-2022
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Stone

Keywords

Renal stone; Retrograde intrarenal surgery; Infectious complications; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after intervention

Secondary Outcomes (2)

• Rate of postoperative fever

  30 days after intervention

• Rate of postoperative UTI

  30 days after intervention

Study Arms (2)

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)

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)

Drug: Extended regimen

Interventions

Enhanced regimen DRUG

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)

Enhanced regimen

Extended regimen DRUG

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)

Extended regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 41460253 DERIVED

MeSH Terms

Conditions

Nephrolithiasis; Sepsis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amr A Elsawy

  Mansoura University

  STUDY DIRECTOR

• Ehab Nour

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Elsawy

CONTACT

01009428750; amrelsawy.unc@hotmail.com

Ehab Nour

CONTACT

daehab1994@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Model Details: 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).

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)