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

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT02479503
Collaborator
(none)
21
1
4
5.2

Study Details

Study Description

Brief Summary

The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Antibiotic prophylaxis in adult heart transplantation

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 Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
French Adult Heart Transplantation Center

All center performing adult heart transplantation in France in 2015.

Procedure: Antibiotic prophylaxis in adult heart transplantation

Outcome Measures

Primary Outcome Measures

  1. Class of antibiotic used as prophylaxis in adult heart transplantation [one year]

Secondary Outcome Measures

  1. Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation [one year]

    elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving

  2. Fungal prophylaxis in adult heart transplantation [one year]

  3. Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All French centers performing adult heart transplantation in 2015
Exclusion Criteria:
  • not responding center

  • no adult heart transplantation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Caen University Hospital Caen Normandy France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT02479503
Other Study ID Numbers:
  • ATC
First Posted:
Jun 24, 2015
Last Update Posted:
Apr 14, 2020
Last Verified:
Jun 1, 2015
Keywords provided by University Hospital, Caen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2020