Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation (BI-PACED)

Universitas Diponegoro

Status and phase: Completed; Phase 4

Conditions: CIED Related Infection; Biomarkers; Heart Block; Antibiotic Prophylaxis; CIED-related Infections

Treatments: Drug: Ampicillin sulbactam 3 days; Drug: Placebo 3 days

Study type: Interventional

Funder types: Other

Identifiers

NCT06448624

No.16114/EC/KEPK-RSDK/2024

Details and patient eligibility

About

Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication of CIED implantation
• No infection at the time of implantation

Exclusion criteria

• Refuse to participate in the study
• Allergy to ampicillin sulbactam
• CIED debridement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention

Placebo Comparator group

Description:

Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation

Treatment:

Drug: Placebo 3 days

Control

Experimental group

Description:

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

Treatment:

Drug: Ampicillin sulbactam 3 days