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:
Participant gender:
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.