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Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections. (ENVELOPE)

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ClinicalTrials.gov Identifier: NCT02809131
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
Thomas Jefferson University
The Cooper Health System
Valley Health System
Medtronic
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Complete Heart Block Syncope Chronic Systolic Heart Failure Drug: polymixin/bacitracin Drug: cephalexin, or levofloxacin, or clindamycin Drug: Saline Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients
Study Start Date : April 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Saline irrigation
Saline irrigation
Drug: Saline
Saline irrigation

Active Comparator: Antibiotic irrigation and PO antibiotics
Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin)
Drug: polymixin/bacitracin
Antibacterial irrigation

Drug: cephalexin, or levofloxacin, or clindamycin
Post operative oral antibiotics
Other Name: Kelfex, Levaquin, Cleocin




Primary Outcome Measures :
  1. Number of patients with a major CIED infection [ Time Frame: 6 months ]
    The primary study endpoint will be the number of patients with CIED infection resulting in complete CIED system removal, antibiotic therapy in patients who are not candidates for system removal, or death due to CIED infection.


Secondary Outcome Measures :
  1. Number of patients with a minor CIED infection [ Time Frame: 6 months ]
    A minor superficial infection of the incision that does not involve the generator pocket, does not result in any systemic symptoms or signs, and is treated with either observation or a short course of oral antibiotics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years old
  • Able to give informed consent
  • At least 2 of the following risk factors for infection:

    • Diabetes mellitus
    • Chronic kidney disease (estimated creatinine clearance <30 ml/min
    • Therapeutic anticoagulation
    • Chronic heart failure
    • Chronic use of corticosteroids
    • Fever ≥38° C or leukocytois (≥11,000 cells/mm3) within 24 hrs of implant
    • Device revision (including generator change, or extraction)
    • ≥3 leads in situ (CRT system or abandoned leads)
    • Early reoperation (pocket re-entry <2 weeks)
    • Previous CIED infection

Exclusion Criteria:

  • Medical condition that is likely to be fatal in less than one year
  • Emergent CIED procedure
  • Allergy to rifampin or minocycline, Allergy to polymyxin-B or bacitracin
  • Enrollment in WRAP-IT trial
  • Current CIED pocket infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809131


Contacts
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Contact: Christopher Ellis, M.D. 615-480-0829 christopher.ellis@Vanderbilt.Edu

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Christopher Ellis, M.D.    615-480-0829    christopher.ellis@Vanderbilt.Edu   
Vanderbilt University Medical Center Enrolling by invitation
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Thomas Jefferson University
The Cooper Health System
Valley Health System
Medtronic
Investigators
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Principal Investigator: Christopher Ellis, M.D. Vanderbilt University Medical Center

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Responsible Party: Christopher Ellis, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02809131     History of Changes
Other Study ID Numbers: 150753
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christopher Ellis, Vanderbilt University Medical Center:
CIED infection
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Infection
Syncope
Heart Failure, Systolic
Heart Block
Heart Failure
Heart Diseases
Cardiovascular Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Anti-Bacterial Agents
Levofloxacin
Ofloxacin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cephalexin
Polymyxins
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents