Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

Antibiotic Prophylaxis Clinical Trial

— ATC  

Official title:

Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479503
• Other study ID #: ATC
• Status: Completed
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All French centers performing adult heart transplantation in 2015

Exclusion Criteria:

• not responding center

• no adult heart transplantation

Related Conditions & MeSH terms

• Adult Heart Transplantation
• Antibiotic Prophylaxis

Intervention

Procedure:
• Antibiotic prophylaxis in adult heart transplantation

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Epub 2001 Aug 6. Review. — View Citation

Ramos A, Asensio A, Muñez E, Torre-Cisneros J, Blanes M, Carratalá 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Class of antibiotic used as prophylaxis in adult heart transplantation		one year
Secondary	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	one year
Secondary	Fungal prophylaxis in adult heart transplantation		one year
Secondary	Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation		one year