NCT02479503

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

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

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 14, 2020

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

June 12, 2015

Last Update Submit

April 13, 2020

Conditions

Antibiotic ProphylaxisAdult Heart Transplantation

Keywords

antibiotic prophylaxis heart transplantation

Outcome Measures

Primary Outcomes (1)

  • Class of antibiotic used as prophylaxis in adult heart transplantation

    one year

Secondary Outcomes (3)

  • Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation

    one year

  • Fungal prophylaxis in adult heart transplantation

    one year

  • Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation

    one year

Study Arms (1)

French Adult Heart Transplantation Center

All center performing adult heart transplantation in France in 2015.

Procedure: Antibiotic prophylaxis in adult heart transplantation

Interventions

Antibiotic prophylaxis in adult heart transplantationPROCEDURE
French Adult Heart Transplantation Center

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All French centers perfoming adult heart transplantation in 2015.

You may qualify if:

  • All French centers performing adult heart transplantation in 2015

You may not qualify if:

  • not responding center
  • no adult heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Normandy, 14000, France

Location

Related Publications (3)

  • Zuckermann A, Barten MJ. Surgical wound complications after heart transplantation. Transpl Int. 2011 Jul;24(7):627-36. doi: 10.1111/j.1432-2277.2011.01247.x. Epub 2011 Mar 21.

    PMID: 21418335BACKGROUND

  • Montoya JG, Giraldo LF, Efron B, Stinson EB, Gamberg P, Hunt S, Giannetti N, Miller J, Remington JS. Infectious complications among 620 consecutive heart transplant patients at Stanford University Medical Center. Clin Infect Dis. 2001 Sep 1;33(5):629-40. doi: 10.1086/322733. Epub 2001 Aug 6.

    PMID: 11486285BACKGROUND

  • Ramos A, Asensio A, Munez E, Torre-Cisneros J, Blanes M, Carratala J, Segovia J, Munoz P, Cisneros JM, Bou G, Aguado JM, Cervera C, Gurgui MM. Incisional surgical infection in heart transplantation. Transpl Infect Dis. 2008 Jul;10(4):298-302. doi: 10.1111/j.1399-3062.2008.00316.x. Epub 2008 May 15.

    PMID: 18482203BACKGROUND

MeSH Terms

Interventions

Antibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

ChemopreventionDrug TherapyTherapeuticsPremedication

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 24, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

April 14, 2020

Record last verified: 2015-06

Locations

FR(1)