Phase 3 N=98 Randomized Other

Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

Kidney Stones

Bottom Line

View on ClinicalTrials.gov: NCT02579161 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Mar 2023

Primary outcome: Primary: Number of Participants With Infectious Complications — 6; 7; 6; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: cephalosporins (Drug); Fluoroquinolones (Drug); Clindamycin (Drug); Ampicillin/Gentamicin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwell Health
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Infectious Complications	6; 7; 6; 8; 1; 2	—
SECONDARY Length of Stay (Days)	1.7; 1.5	—
SECONDARY Number of Participants With Associated Clavien Grade of Adverse Event	4; 3; 2; 5; 3; 2	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02579161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.