ClinicalTrials.gg
Not yet recruitingNCT07788417ENVIR-TRANSUpdated Aug 31, 2026

Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

An observational study in Transplantation Infection and Pulmonary Transplantation, sponsored by Fondation Hôpital Saint-Joseph. Not yet recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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%).

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.

02

Conditions studied

  • Transplantation Infection
  • Pulmonary Transplantation
03

In context

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.

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

04

Who can participate

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

Study population

Adult patients who have received a lung transplant or a heart-lung transplant.

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

8 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.

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

Registered
Aug 4, 2026
First posted
Aug 26, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Mar 15, 2028
CompletionEst.
Mar 15, 2028
Last update
Aug 31, 2026
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 Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07788417
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Mar 15, 2028 (estimated)
Completion
Mar 15, 2028 (estimated)
Last update
Aug 31, 2026

Study contacts

Benoît PILMIS;, MD
Contact
bpilmis@ghpsj.fr
01.44.12.78.20

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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