NCT06448624

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

May 28, 2024

Last Update Submit

February 24, 2025

Conditions

Heart BlockCIED Related InfectionCIED-related InfectionsAntibiotic ProphylaxisBiomarkers

Keywords

heart blockCIED related infectionantibiotic prophylaxisbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Incidence of CIED-related infection

    Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization

    Baseline, 3 days, 7 days, and 28 days

Secondary Outcomes (3)

  • Level of Presepsin

    Baseline and 24 hours after CIED implantation

  • Level of Interleukin-6

    Baseline and 24 hours after CIED implantation

  • Level of Procalcitonin

    Baseline and 24 hours after CIED implantation

Study Arms (2)

Intervention

PLACEBO COMPARATOR

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

Drug: Placebo 3 days

Control

EXPERIMENTAL

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

Interventions

Ampicillin sulbactam 3 daysDRUG

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

Control
Placebo 3 daysDRUG

Placebo for 3 days after CIED implantation

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kariadi Central General Hospital

Semarang, Central Java, 50244, Indonesia

Location

MeSH Terms

Conditions

Heart Block

Interventions

sultamicillin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 7, 2024

Study Start

April 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

ID(1)