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NCT02384200 · ClinicalTrials.gov registry record · Phase 4
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 86
- Enrollment target
NCT02384200 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 86 participants.
The verdict
NCT02384200, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 86 participants
- Enrollment target
Study Summary
When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy \[PCNL\]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
Interventions
- DRUG ceftriaxone
- DRUG gentamicin
- DRUG vancomycin
- DRUG nitrofurantoin monohydrate/macrocrystalline capsules
- DRUG ampicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2015-03 |
| Est. Completion | 2019-06-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02384200
The ClinicalTrials.gov registry entry for NCT02384200 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which ceftriaxone is the first listed.
NCT02384200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02384200 about?
NCT02384200 is a clinical study titled "A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])". When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy \[PCNL\]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophyl...
What is the current status of trial NCT02384200?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2015-03. Estimated completion is 2019-06-01.
What interventions are being tested in trial NCT02384200?
The interventions under investigation include: ceftriaxone (DRUG), gentamicin (DRUG), vancomycin (DRUG), nitrofurantoin monohydrate/macrocrystalline capsules (DRUG), ampicillin (DRUG).
Who is sponsoring clinical trial NCT02384200?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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