A Phase 4 interventional study of Ampicillin sulbactam 3 days and Placebo 3 days in Heart Block, CIED Related Infection and CIED-related Infections, sponsored by Universitas Diponegoro. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Universitas Diponegoro · Phase 4, Interventional, and Prevention
Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Universitas Diponegoro is the lead sponsor of 23 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation
Drug: Placebo 3 days
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + ampicillin sulbactam 1.5 gram IV BID for 3 days after implantation
Drug: Ampicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation
Placebo for 3 days after CIED implantation
Incidence of CIED-related infection
Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization
Time frame: Baseline, 3 days, 7 days, and 28 days
Level of Presepsin
Delta level of Presepsin
Time frame: Baseline and 24 hours after CIED implantation
Level of Interleukin-6
Delta level of Interleukin-6
Time frame: Baseline and 24 hours after CIED implantation
Level of Procalcitonin
Delta level of Procalcitonin
Time frame: Baseline and 24 hours after CIED implantation
Plan to share: Undecided — Waiting for agreement
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Universitas Diponegoro