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NCT02829060 · ClinicalTrials.gov registry record · NA
Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
NCT02829060: Completed NA study, sponsored by University of California, San Diego.
NCT02829060 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 330 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02829060, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
Study Summary
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to undergoing percutaneous nephrolithotomy. The select patient population will be those patients deemed to be at a moderately increased risk of postoperative infectious complications. These higher risk patients are those with indwelling urinary drainage tubes and those with a positive preoperative urine culture.
Primary Outcome
Sepsis will be defined by the 2012 International Guidelines for the Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated * Temp \> 38.3C or \<36C * 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 \<70 mmH
Interventions
- DRUG Nitrofurantoin 100 MG, 7d
- DRUG Gentamicin, 5mg/kg
- DRUG Ampicillin 2g
- DRUG Nitrofurantoin 100 mg, 48 hrs
- DRUG Gentamicin, 80 mg, 7d
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2016-01 |
| Est. Completion | 2025-03 |
| Phase | NA |
What the finished NCT02829060 record still lists
NCT02829060 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Nitrofurantoin 100 MG, 7d is the first listed.
NCT02829060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02829060 about?
NCT02829060 is a clinical study titled "Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2". This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to undergoing percutaneous nephrolithotomy. The select patient population will be those patients deemed to be at a moderately in...
What is the current status of trial NCT02829060?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2016-01. Estimated completion is 2025-03.
What interventions are being tested in trial NCT02829060?
The interventions under investigation include: Nitrofurantoin 100 MG, 7d (DRUG), Gentamicin, 5mg/kg (DRUG), Ampicillin 2g (DRUG), Nitrofurantoin 100 mg, 48 hrs (DRUG), Gentamicin, 80 mg, 7d (DRUG).
Who is sponsoring clinical trial NCT02829060?
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 NCT02829060's enrollment target sits among peer trials
330 307th of 2000 higher than 1,693 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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