Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

NCT02579161 | Completed Phase 3 Results DMC

• 1 other identifier: 14-003
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

Conditions

Kidney Stones

Keywords

Percutaneous Nephrolithotomy; Kidney Stones; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Infectious Complications

  Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.

  0-30 days post-operatively

Secondary Outcomes (2)

• Length of Stay (Days)

  0-30 days post operatively

• Number of Participants With Associated Clavien Grade of Adverse Event

  0 to 30 days after surgery

Study Arms (2)

Antibiotics for a 24 hour period

ACTIVE COMPARATOR

Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc.

Drug: cephalosporins; Drug: Fluoroquinolones; Drug: Clindamycin; Drug: Ampicillin/Gentamicin

Continued antibiotics

ACTIVE COMPARATOR

Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.

Drug: cephalosporins; Drug: Fluoroquinolones; Drug: Clindamycin; Drug: Ampicillin/Gentamicin

Interventions

cephalosporins DRUG

Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed

Also known as: ancef

Antibiotics for a 24 hour period; Continued antibiotics

Fluoroquinolones DRUG

If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance

Also known as: ciprofloxacin

Antibiotics for a 24 hour period; Continued antibiotics

Clindamycin DRUG

If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.

Also known as: Lincosamides

Antibiotics for a 24 hour period; Continued antibiotics

Ampicillin/Gentamicin DRUG

5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin

Also known as: Penicillinase-sensitive penicillin\Aminoglycoside

Antibiotics for a 24 hour period; Continued antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Negative urine culture within 1 month prior to procedure
• Renal Calculi which would optimally require PCNL for treatment.

You may not qualify if:

• Patients \<18 years old.
• Patients who are not able to give consent for study
• Patients currently on antibiotics immediately prior to the procedure
• Previous history of sepsis or SIRS from stone manipulations
• Foley catheter in place for greater than 1 week duration
• Patients under going planned, multi-staged procedures
• Immunosuppressed patients

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

• Griffiths L, Aro T, Samson P, Derisavifard S, Gaines J, Alaiev D, Mullen G, Rai A, Williams T, Patel V, Guanay G, Leavitt D, Hartman C, Smith A, Hoenig D, Okeke Z. Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients. J Endourol. 2023 Oct;37(10):1075-1080. doi: 10.1089/end.2022.0678.

  PMID: 37578113 DERIVED

MeSH Terms

Conditions

Kidney Calculi

Interventions

Cephalosporins; Cefazolin; Fluoroquinolones; Ciprofloxacin; Clindamycin; Lincosamides; Ampicillin; Gentamicins

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 4-Quinolones; Quinolones; Quinolines; Lincomycin; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Penicillin G; Penicillins; Aminoglycosides

Limitations and Caveats

Procedure included tubeless procedures. While this may aid in generalizability, an element of antibiotic duration variation is unavoidably introduced in this treatment arm. The original design was to have 290 participants, due to the low number of recruitment, this number was reduced to a goal of 100 total with 50 randomized to each arm. This limits the analysis, but ultimately desired measures were achieved.

Results Point of Contact

• Title: Dr. Zeph Okeke
• Organization: Northwell Health

zokeke@northwell.edu

516-734-8500

Study Officials

• Zeph Okeke, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: October 19, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 6, 2023
• Results First Posted: March 14, 2023

Record last verified: 2023-09

Locations

US (2)