Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation
NCT ID: NCT06448624
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2024-04-01
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation
Placebo 3 days
Placebo for 3 days after CIED implantation
Control
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
Ampicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation
Interventions
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Ampicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation
Placebo 3 days
Placebo for 3 days after CIED implantation
Eligibility Criteria
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Inclusion Criteria
* No infection at the time of implantation
Exclusion Criteria
* Allergy to ampicillin sulbactam
* CIED debridement
ALL
No
Sponsors
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Dr. Kariadi General Hospital Medical Center
OTHER
Universitas Diponegoro
OTHER
Responsible Party
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Pipin Ardhianto
Principal investigator
Locations
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Kariadi Central General Hospital
Semarang, Central Java, Indonesia
Countries
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Other Identifiers
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No.16114/EC/KEPK-RSDK/2024
Identifier Type: -
Identifier Source: org_study_id
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