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CompletedNCT02479503ATCUpdated Apr 14, 2020

Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

An observational study in Antibiotic Prophylaxis and Adult Heart Transplantation, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
21
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Antibiotic Prophylaxis
  • Adult Heart Transplantation

Keywords

  • antibiotic prophylaxis heart transplantation
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In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 510 studies on the registry; 80 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All French centers perfoming adult heart transplantation in 2015.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All French centers performing adult heart transplantation in 2015

Exclusion criteria

Exclusion Criteria:

  • not responding center
  • no adult heart transplantation
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Study design

Observational model
Other
Time perspective
Other
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • French Adult Heart Transplantation Center

    All center performing adult heart transplantation in France in 2015.

    Procedure: Antibiotic prophylaxis in adult heart transplantation

Interventions

  • ProcedureAntibiotic prophylaxis in adult heart transplantation
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What researchers measure

Primary outcomes

  1. Class of antibiotic used as prophylaxis in adult heart transplantation

    Time frame: one year

Secondary outcomes

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

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

    Time frame: one year

  2. Fungal prophylaxis in adult heart transplantation

    Time frame: one year

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

    Time frame: one year

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Study locations

1 site
  • Caen University Hospital
    Caen, Normandy 14000, France
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References and documents

Publications

  • 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. PubMed 21418335 ↗
  • 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. PubMed 11486285 ↗
  • 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. PubMed 18482203 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of Jun 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2015
First posted
Jun 24, 2015
Start
Mar 2015
Primary completionActual
Jun 2015
CompletionActual
Jul 2015
Last update
Apr 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02479503
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Jul 2015
Last update
Apr 14, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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