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

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaplan Medical Center
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cephalexin; Polystyrene sulfonic acid; Roxithromycin

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.