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NCT02809131 · ClinicalTrials.gov registry record · Phase 3
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
A Phase 3 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,010
- Enrollment target
NCT02809131 is a Phase 3 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 1,010 participants.
The verdict
NCT02809131, a Phase 3 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,010 participants
- Enrollment target
Study Summary
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or intravascular leads, have become increasingly prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds of both short term and long term mortality are at least doubled in patients who suffer CIED infections, and long term survival is particularly poor in women. Optimal strategies to prevent CIED infections in high-risk patients are largely unproven. However, recent observational studies of an antibiotic-coated envelope implanted at the time of CIED procedure have shown that this strategy is associated with a low incidence of CIED infections. Other interventions to prevent CIED infections, including the use of antibiotic irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are commonly used but not supported by rigorous controlled studies. The Specific Aim of this study is to test the hypothesis that the use of the antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.
Interventions
- DRUG Saline
- DRUG polymixin/bacitracin
- DRUG cephalexin, or levofloxacin, or clindamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,010 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02809131
The ClinicalTrials.gov registry entry for NCT02809131 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,010 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Saline is the first listed.
NCT02809131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02809131 about?
NCT02809131 is a clinical study titled "Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.". The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or intravascular leads, have become increasingly prevalent, with the rate of growth i...
What is the current status of trial NCT02809131?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,010 participants. The study started on 2016-04-01. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02809131?
The interventions under investigation include: Saline (DRUG), polymixin/bacitracin (DRUG), cephalexin, or levofloxacin, or clindamycin (DRUG).
Who is sponsoring clinical trial NCT02809131?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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