Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT02384200 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 86 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
"Sepsis" will be defined by the 2012 International Guidelines for Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated * Temp \> 38.3 C or \<36 C * Heart Rate \> 90/min (at least 12 hrs after surgery) * Respiratory Rate \> 20/min (at least 12 hrs after surgery) * Altered mental status: defined as lack of orientation to either name, place, or time/date. * Systolic Blood Pressure (SBP) \< 90 mmHg, Mean Arterial Pressure \< 7
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 |
What the finished NCT02384200 record still lists
NCT02384200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which ceftriaxone is the first listed.
NCT02384200 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02384200's enrollment target sits among peer trials
86 926th of 2000 higher than 1,073 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01639508 · 86 participants · Phase 2
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
- NCT03519269 · 86 participants · NA
Navio Robotic Versus Conventional Total Knee Arthroplasty
- NCT04132999 · 86 participants · NA
PAP for Children With DS and OSAS
- NCT04545957 · 86 participants · NA
Jump: MR Simulation For Radiation Therapy Master Protocol
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia