Transplantation InfectionENVIR-TRANSNCT07788417
Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation
An observational study of Transplantation Infection and Pulmonary Transplantation, run by Fondation Hôpital Saint-Joseph at 8 sites in France.
Trial summary
Solid organ transplantation (lung, kidney, liver, and heart) is a major therapeutic option for many end-stage chronic diseases. In France, several hundred patients undergo transplantation each year, supported by advances in surgery, immunosuppression, and care organization (e.g., 308 lung transplants in 2023, +2.5%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation Infection, Pulmonary Transplantation
- How many people
- 1,000 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Sep 2026to 15 Mar 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have received a lung transplant or a heart-lung transplant.
Who may be able to join
- Patient aged 18 years or older at the time of transplantation
- French-speaking patient
- Patient who has undergone a lung transplantation or a heart-lung transplantation
Who cannot join
- Patients under legal guardianship or curatorship
- Patients deprived of their liberty
- Patients subject to a judicial protection measure (safeguard of justice)
- Patients who object to the use of their data for the purposes of this study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Hôpital Haut-Lévêque-Pessac, Bordeaux
Bordeaux
Hôpital Louis Pradel - Lyon
Lyon
Claire Merveilleux Du Vignaux, MD
Hôpital Nord - Marseille
Marseille
Hôpital Nord Saint-Herblain- Nantes
Nantes
Adrien TISSOT, MD
Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
Hôpital Bichat
Paris
Gaëlle WEISENBURGER, MD
CHRU Strasbourg
Strasbourg
Benjamin RENAUD-PICARD, MD
Hôpital Foch
Suresnes
About this study
Solid organ transplantation (lung, kidney, liver, and heart) is a major therapeutic option for many end-stage chronic diseases. In France, several hundred patients undergo transplantation each year, supported by advances in surgery, immunosuppression, and care organization (e.g., 308 lung transplants in 2023, +2.5%).
This trend includes broader indications, greater use of "marginal" donors, and an ageing recipient population (mean age of lung transplant recipients: 53 years in 2022). Infections remain a leading cause of post-transplant morbidity and mortality: up to 19.2% of early deaths and the main cause of death in the first year. Incidence is especially high after lung transplantation, and the infection risk persists lifelong.
Read more
Patients receive education on high-risk exposures (food, travel, social contacts, animals, leisure), yet no standardized international guidelines exist. In France, counseling varies widely between centers and is often based on limited evidence. Patient adherence is poorly documented and sometimes low (≈18% for dietary advice).
No French data currently describe the actual recommendations given, how patients apply them, or their impact on quality of life. We therefore propose a multicenter cross-sectional study in lung (and heart-lung) transplant recipients to describe the recommendations provided, assess their concordance with patient behaviors, and identify discrepancies. Findings may help harmonize recommendations while accounting for the specificities of lung transplantation. The study will later be extended to kidney, liver, and heart transplant recipients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional
Measured: single self-administered questionnaire completed at enrolment; one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788417
- Sponsor's protocol ID
- 2026-A00507-44
- Acronym
- ENVIR-TRANS
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT07788417
- Acronym / sponsor ID
- ENVIR-TRANS / 2026-A00507-44
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- 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.
Solid organ transplantation (lung, kidney, liver, and heart) is a major therapeutic option for many end-stage chronic diseases. In France, several hundred patients undergo transplantation each year, supported by advances in surgery, immunosuppression, and care organization (e.g., 308 lung transplants in 2023, +2.5%).
This trend includes broader indications, greater use of "marginal" donors, and an ageing recipient population (mean age of lung transplant recipients: 53 years in 2022). Infections remain a leading cause of post-transplant morbidity and mortality: up to 19.2% of early deaths and the main cause of death in the first year. Incidence is especially high after lung transplantation, and the infection risk persists lifelong.
Patients receive education on high-risk exposures (food, travel, social contacts, animals, leisure), yet no standardized international guidelines exist. In France, counseling varies widely between centers and is often based on limited evidence. Patient adherence is poorly documented and sometimes low (≈18% for dietary advice).
No French data currently describe the actual recommendations given, how patients apply them, or their impact on quality of life. We therefore propose a multicenter cross-sectional study in lung (and heart-lung) transplant recipients to describe the recommendations provided, assess their concordance with patient behaviors, and identify discrepancies. Findings may help harmonize recommendations while accounting for the specificities of lung transplantation. The study will later be extended to kidney, liver, and heart transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have received a lung transplant or a heart-lung transplant.
Key inclusion criteria (3 listed)
- Patient aged 18 years or older at the time of transplantation
- French-speaking patient
- Patient who has undergone a lung transplantation or a heart-lung transplantation
Key exclusion criteria (4 listed)
- Patients under legal guardianship or curatorship
- Patients deprived of their liberty
- Patients subject to a judicial protection measure (safeguard of justice)
- Patients who object to the use of their data for the purposes of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional
Time frame: single self-administered questionnaire completed at enrolment; one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation Infection and Pulmonary Transplantation, run by Fondation Hôpital Saint-Joseph at 8 sites 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoît PILMIS;, MD (01.44.12.78.20, bpilmis@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional (time frame: single self-administered questionnaire completed at enrolment; one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.