Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.

NCT02809131 | Completed Phase 3 Results

• 1 other identifier: 150753
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 1

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.

Conditions

Sick Sinus Syndrome; Complete Heart Block; Syncope; Chronic Systolic Heart Failure

Keywords

CIED infection

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection

  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.

  6 months

Secondary Outcomes (1)

• Number of Patients With a Minor Cardiac Implantable Electronic Devices (CIED) Infection

  6 months

Study Arms (2)

Saline irrigation

EXPERIMENTAL

Saline irrigation

Drug: Saline

Antibiotic irrigation and PO antibiotics

ACTIVE COMPARATOR

Antibacterial irrigant (polymyxinB/bacitracin) and postoperative oral antibiotics (cephalexin, clindamycin, or levofloxacin)

Drug: polymixin/bacitracin; Drug: cephalexin, or levofloxacin, or clindamycin

Interventions

polymixin/bacitracin DRUG

Antibacterial irrigation

Antibiotic irrigation and PO antibiotics

cephalexin, or levofloxacin, or clindamycin DRUG

Post operative oral antibiotics

Also known as: Kelfex, Levaquin, Cleocin

Antibiotic irrigation and PO antibiotics

Saline DRUG

Saline irrigation

Saline irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Thomas Jefferson University: collaborator
• The Cooper Health System: collaborator
• Valley Health System: collaborator
• Medtronic: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Ellis CR, Greenspon AJ, Andriulli JA, Gould PA, Carillo RG, Kolek MJ, Donegan R, Amaral AP, Mittal S. Randomized Trial of Stand-Alone Use of the Antimicrobial Envelope in High-Risk Cardiac Device Patients. Circ Arrhythm Electrophysiol. 2023 May;16(5):e011740. doi: 10.1161/CIRCEP.122.011740. Epub 2023 Mar 24.

  PMID: 36960716 DERIVED

MeSH Terms

Conditions

Sick Sinus Syndrome; Syncope

Interventions

Bacitracin; Cephalexin; Levofloxacin; Clindamycin; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Christopher R. Ellis, MD, FACC, FHRS
• Organization: Vanderbilt University Medical Center

Christopher.ellis@vumc.org

(615)-936-2523

Study Officials

• Christopher Ellis, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: June 22, 2016
• Study Start: April 1, 2016
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)