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NCT01764750 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01764750 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT01764750, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to \~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially catastrophic consequences. Given this, the high cost of treatment, and a payer system unable to support such expenses, investigators must make every effort to find new cost-effective ways to prevent these complications. Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin into spinal surgery wounds immediately prior to wound closure. This method, known as "intrasite" application, is adapted from techniques used to prevent infection in joint replacement surgeries. The motivation for this practice is to maximize antibiotic concentration within the wound while minimizing systemic concentration and toxicity, (the inverse of the situation when using IV antibiotics). While the popularity of intrasite delivery has grown rapidly, this has occurred without prospective scientific evidence. Recently, three retrospective papers including nearly 2,500 treated patients, indicated that intrasite Vancomycin reduces wound infections without increasing adverse events\[1-3\]. However, there are no published data on the dosing or pharmacokinetics of intrasite Vancomycin, let alone prospective trials of its efficacy and safety. The investigators propose to perform the first prospective trial of intrasite Vancomycin pharmacokinetics and safety. Study objectives will include standardizing application and dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal potency, and dose selection for use in future studies. This will be accomplished by enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous
Interventions
- DRUG IV Vancomycin
- DRUG Intrasite Vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01764750
The ClinicalTrials.gov registry entry for NCT01764750 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IV Vancomycin is the first listed.
NCT01764750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01764750 about?
NCT01764750 is a clinical study titled "Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics". Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to \~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially cat...
What is the current status of trial NCT01764750?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01764750?
The interventions under investigation include: IV Vancomycin (DRUG), Intrasite Vancomycin (DRUG).
Who is sponsoring clinical trial NCT01764750?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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