Clinical trial NCT02479503: Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Official title: Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Prophylaxis
Adult Heart Transplantation
Keywords: antibiotic prophylaxis heart transplantation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All French centers perfoming adult heart transplantation in 2015.

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

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.

Eligibility criteria: Inclusion Criteria:

* All French centers performing adult heart transplantation in 2015

Exclusion Criteria:

* not responding center
* no adult heart transplantation

Primary outcomes:
measure: Class of antibiotic used as prophylaxis in adult heart transplantation
timeFrame: one year
Secondary outcomes:
measure: Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation
timeFrame: one year
measure: Fungal prophylaxis in adult heart transplantation
timeFrame: one year
measure: Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation
timeFrame: one year
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.