NCT04736979

Brief Summary

This study was aimed at the evaluation of a new protocol of antibiotic prophylaxis, stratified according to individual infective risk calculated with the Shariff score at the moment of cardiac implantable electronic device (CIED) implantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,044

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

January 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

3.7 years

First QC Date

January 27, 2021

Last Update Submit

April 23, 2022

Conditions

Device Related Infection

Keywords

pacemakerimplantable cardioverter defibrillatorcardiac implantable electronic deviceinfectionantibioticShariff score

Outcome Measures

Primary Outcomes (1)

  • CIED related infection

    clinical diagnosis of systemic or local infection involving subcutaneous CIED pocket or intravenous/intracardiac CIED lead or sepsis

    6 months

Interventions

amoxicillin clavulanateDRUG

dosage according to Shariff score and creatinine clearance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing CIED-related intervention

You may qualify if:

  • first implantation or replacement or upgrade of pacemaker or ICD

You may not qualify if:

  • age 18 years
  • ongoing pregnancy
  • inability to express informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Malagu M, Vitali F, Brieda A, Cimaglia P, De Raffele M, Tazzari E, Musolino C, Balla C, Serenelli M, Cultrera R, Rapezzi C, Bertini M. Antibiotic prophylaxis based on individual infective risk stratification in cardiac implantable electronic device: the PRACTICE study. Europace. 2022 Mar 2;24(3):413-420. doi: 10.1093/europace/euab222.

    PMID: 34487163RESULT

MeSH Terms

Conditions

Prosthesis-Related InfectionsInfections

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Matteo Bertini

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 3, 2021

Study Start

January 1, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share