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

February 24, 2025 updated by: Pipin Ardhianto, Universitas Diponegoro

Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50244
        • Kariadi Central General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Intervention
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation
Drug: Placebo 3 days
Placebo for 3 days after CIED implantation
Experimental: 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
Drug: Ampicillin sulbactam 3 days
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of CIED-related infection
Time Frame: Baseline, 3 days, 7 days, and 28 days
Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization
Baseline, 3 days, 7 days, and 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Presepsin
Time Frame: Baseline and 24 hours after CIED implantation
Delta level of Presepsin
Baseline and 24 hours after CIED implantation
Level of Interleukin-6
Time Frame: Baseline and 24 hours after CIED implantation
Delta level of Interleukin-6
Baseline and 24 hours after CIED implantation
Level of Procalcitonin
Time Frame: Baseline and 24 hours after CIED implantation
Delta level of Procalcitonin
Baseline and 24 hours after CIED implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Collaborators

Dr. Kariadi General Hospital Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.16114/EC/KEPK-RSDK/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Waiting for agreement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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