Phase 3
Completed N=98
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Source: ClinicalTrials.gov NCT02579161 ↗Enrolled (actual)
98
Serious AEs
3.1%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Infectious Complications — 6; 7; 6; 8 Participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients.
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.
Linked Publications
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Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02579161) and the linked publication. 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. Informational only — not medical advice.