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Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation

NCT06448624 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-27

No results posted yet for this study

Summary

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

Conditions

  • Heart Block
  • CIED Related Infection
  • CIED-related Infections
  • Antibiotic Prophylaxis
  • Biomarkers

Interventions

DRUG

Ampicillin sulbactam 3 days

Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation

DRUG

Placebo 3 days

Placebo for 3 days after CIED implantation

Sponsors & Collaborators

  • Dr. Kariadi General Hospital Medical Center

    collaborator OTHER

  • Universitas Diponegoro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448624 on ClinicalTrials.gov