Antibiotic ProphylaxisATCNCT02479503
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
An observational study of Antibiotic Prophylaxis and Adult Heart Transplantation, run by University Hospital, Caen at 1 site in France.
Trial summary
The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibiotic Prophylaxis, Adult Heart Transplantation
- What is being tested?
- Antibiotic prophylaxis in adult heart transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All French centers perfoming adult heart transplantation in 2015.
Who may be able to join
- All French centers performing adult heart transplantation in 2015
Who cannot join
- not responding center
- no adult heart transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Antibiotic prophylaxis in adult heart transplantation
- Keywords
- antibiotic prophylaxis heart transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic prophylaxis in adult heart transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| French Adult Heart Transplantation Center | All center performing adult heart transplantation in France in 2015. Receives: Procedure: Antibiotic prophylaxis in adult heart transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Class of antibiotic used as prophylaxis in adult heart transplantation
Measured: one year
Secondary outcomes (3)
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
Measured: one year
Fungal prophylaxis in adult heart transplantation
Measured: one year
Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479503
- Sponsor's protocol ID
- ATC
- Acronym
- ATC
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2015
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
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 21418335Montoya 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 11486285Ramos 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
- ClinicalTrials.gov ID
- NCT02479503
- Acronym / sponsor ID
- ATC / ATC
- Keywords
- antibiotic prophylaxis heart transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| French Adult Heart Transplantation Center | – | Procedure: Antibiotic prophylaxis in adult heart transplantationAll center performing adult heart transplantation in France in 2015. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All French centers perfoming adult heart transplantation in 2015.
Key inclusion criteria (1 listed)
- All French centers performing adult heart transplantation in 2015
Key exclusion criteria (2 listed)
- not responding center
- no adult heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic prophylaxis in adult heart transplantation | Procedure or surgery | French Adult Heart Transplantation Center |
Primary outcome
Class of antibiotic used as prophylaxis in adult heart transplantation
Time frame: one year
3 secondary outcomes
Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation
Time frame: one year
Fungal prophylaxis in adult heart transplantation
Time frame: one year
Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 21418335Zuckermann 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.
- Background: PubMed 11486285Montoya 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.
- Background: PubMed 18482203Ramos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Prophylaxis and Adult Heart Transplantation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Class of antibiotic used as prophylaxis in adult heart transplantation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479503, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.