Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome

NCT03148444 | Unknown Phase 4 DMC

• 1 other identifier: kmc 0038-16
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion. The role of antibiotic prophylaxis in prevention of this complication is well established. Most centres in Israel currently prescribe antibiotics about 5 days following the procedure as well, though clear clinical evidence warranting this practise is lacking. Unnecessary antibiotic treatment can lead to adverse events including allergy, undesirable effects of the antibiotics, establishment of resistance to antibiotics among bacteria and further infections with resistant strains. Objective: The investigators hope to either establish evidence warranting use of post-procedural antibiotic treatment or refuting it. Methods: The investigators intend to recruit about 400 patients a year into both trial group and control group. The trial group will be treated with post-procedural antibiotics during 5 days, while the control group will receive no post-procedural antibiotics. The endpoints of the study will include infections related to the implantable device and proposed adverse effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit exists concerning one of the groups.

Conditions

Infection, Bacterial; Pacemaker Complication

Outcome Measures

Primary Outcomes (3)

• wound infection

  operative wound infection or infection of the device pouch

  1 year

• bacteremia and vegetations

  bacteremia due to device infection, lead vegetation, right infective endocarditis

  1 year

• re-operation

  re-operation due to infective complications

  1 year

Secondary Outcomes (4)

• infection unrelated to implantation

  1 year

• hospitalization

  1 year

• adverse event of antibiotics

  1 year

• death from any cause

  1 year

Study Arms (2)

Antibiotics treated

EXPERIMENTAL

Patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxithromycin 150 mg bid)

Drug: cefalexin 500 mg qid or roxithromycin 150 mg bid

without Antibiotics Treatment

NO INTERVENTION

Patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with no recommendations regarding antibiotic treatment.

Interventions

cefalexin 500 mg qid or roxithromycin 150 mg bid DRUG

antibiotics treatment for five days following implantation of cardiac device

Antibiotics treated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution.

You may not qualify if:

• procedure during which, according to the opinion of the operator, the risk of the contamination would be unusually high (for ex. due to prolonged duration) so that obligatory post-operative use of antibiotics should be warranted,
• patients with any immunosuppressive condition (including cytotoxic chemotherapy, chronic use of glucocorticoids, however excluding diabetes mellitus, renal failure and heart failure);
• malignancy,
• pregnancy and breastfeeding;
• hepatic cirrhosis;
• end stage renal disease (GFR\<10 mL/min);
• known allergy to both antibiotic medications used in the study.

Sponsors & Collaborators

• Kaplan Medical Center: lead

Related Publications (8)

• Uslan DZ, Sohail MR, St Sauver JL, Friedman PA, Hayes DL, Stoner SM, Wilson WR, Steckelberg JM, Baddour LM. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch Intern Med. 2007 Apr 9;167(7):669-75. doi: 10.1001/archinte.167.7.669.

  PMID: 17420425 BACKGROUND

• Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. doi: 10.1161/CIRCULATIONAHA.106.678664. Epub 2007 Aug 27.

  PMID: 17724263 BACKGROUND

• Smith PN, Vidaillet HJ, Hayes JJ, Wethington PJ, Stahl L, Hull M, Broste SK. Infections with nonthoracotomy implantable cardioverter defibrillators: can these be prevented? Endotak Lead Clinical Investigators. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 1):42-55. doi: 10.1111/j.1540-8159.1998.tb01060.x.

  PMID: 9474647 BACKGROUND

• Da Costa A, Lelievre H, Kirkorian G, Celard M, Chevalier P, Vandenesch F, Etienne J, Touboul P. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation. 1998 May 12;97(18):1791-5. doi: 10.1161/01.cir.97.18.1791.

  PMID: 9603533 BACKGROUND

• Da Costa A, Kirkorian G, Cucherat M, Delahaye F, Chevalier P, Cerisier A, Isaaz K, Touboul P. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998 May 12;97(18):1796-801. doi: 10.1161/01.cir.97.18.1796.

  PMID: 9603534 BACKGROUND

• de Oliveira JC, Martinelli M, Nishioka SA, Varejao T, Uipe D, Pedrosa AA, Costa R, D'Avila A, Danik SB. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):29-34. doi: 10.1161/CIRCEP.108.795906. Epub 2009 Feb 10.

  PMID: 19808441 BACKGROUND

• Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR, Steckelberg JM, Stoner S, Baddour LM. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007 May 8;49(18):1851-9. doi: 10.1016/j.jacc.2007.01.072. Epub 2007 Apr 23.

  PMID: 17481444 BACKGROUND

• Lekkerkerker JC, van Nieuwkoop C, Trines SA, van der Bom JG, Bernards A, van de Velde ET, Bootsma M, Zeppenfeld K, Jukema JW, Borleffs JW, Schalij MJ, van Erven L. Risk factors and time delay associated with cardiac device infections: Leiden device registry. Heart. 2009 May;95(9):715-20. doi: 10.1136/hrt.2008.151985. Epub 2008 Nov 26.

  PMID: 19036758 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Interventions

Cephalexin; Roxithromycin; BID protein, human

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Central Study Contacts

Moshe Swissa, MD

CONTACT

97250873523; Swissam@clalit.org.il

Igor Volodarsky, MD

CONTACT

972526301769; woland1978@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The random assignment will be performed by a researcher from the cardiologic team performing the implantation by means of choosing one of two closed envelopes. The treatment will not be placebo-controlled, and therefore the neither the patients nor the attending physicians will not be blinded to the final results of the assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Electrophysiology and Pacing Unit

Model Details: We propose to organize a randomized open-label study in which patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) will be randomly assigned to one of the two groups. Patients in one group will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxythromycin 150 mg bid) while in the other group no recommendations regarding antibiotic treatment will be given. Both groups will receive antibiotic prophylaxis before the procedure according to the current recommendations. In both groups, the aseptic technique during the procedure will be observed, and proper hygienic measures past the implantation will be taken.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 11, 2017

Record last verified: 2017-05