Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey (ATC)

April 13, 2020 updated by: University Hospital, Caen
The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In adult heart transplantation, clinical situations differ between patients (elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving). At investigator's knowledge, there is not recommendations in France about antibiotic prophylaxis in adult heart transplantation. So, investigators aimed to study the antibiotic prophylaxis use in adult heart transplantation in France.

Investigators conduct a French national survey about antibiotic prophylaxis used in adult heart transplantation center. Clinical situations such as elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving are investigated.

Study was performed after Institutional approval was obtained from the local Ethics Committee (Comite de Protection des Personnes Nord Ouest III). An electronic survey was sent to all French adult heart transplantation centers (22) on march 1st, 2015. Reminders were planned on week 2 and 4 after initial sending. On june 2015, nonresponding centers were contacted by phone. Data were collected by a single investigator.

Study Type

Observational

Enrollment (Actual)

21

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

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • CAEN University 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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All French centers perfoming adult heart transplantation in 2015.

Description

Inclusion Criteria:

  • All French centers performing adult heart transplantation in 2015

Exclusion Criteria:

  • not responding center
  • no adult heart transplantation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
French Adult Heart Transplantation Center
All center performing adult heart transplantation in France in 2015.
Procedure: Antibiotic prophylaxis in adult heart transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Class of antibiotic used as prophylaxis in adult heart transplantation
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation
Time Frame: one year
elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving
one year
Fungal prophylaxis in adult heart transplantation
Time Frame: one year
one year
Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATC

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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