Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation (ENVIR-TRANS)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Benoît PILMIS;, MD
- Telefonnummer: 01.44.12.78.20
- E-mail: bpilmis@ghpsj.fr
Studiesteder
-
-
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Bordeaux, Frankrig
- Hôpital Haut-Lévêque-Pessac, Bordeaux
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Lyon, Frankrig
- Hôpital Louis Pradel - Lyon
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Ledende efterforsker:
- Claire Merveilleux Du Vignaux, MD
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Marseille, Frankrig
- Hôpital Nord - Marseille
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Nantes, Frankrig
- Hôpital Nord Saint-Herblain- Nantes
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Ledende efterforsker:
- Adrien TISSOT, MD
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Paris, Frankrig
- Hôpital Bichat
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Ledende efterforsker:
- Gaëlle WEISENBURGER, MD
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Strasbourg, Frankrig
- CHRU Strasbourg
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Ledende efterforsker:
- Benjamin RENAUD-PICARD, MD
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Suresnes, Frankrig
- Hôpital Foch
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Groupe Hospitalier Paris Saint-Joseph
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Paris, Groupe Hospitalier Paris Saint-Joseph, Frankrig, 75014
- Groupe Hospitalier Paris Saint-Joseph
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional
Tidsramme: single self-administered questionnaire completed at enrolment; one day
|
single self-administered questionnaire completed at enrolment; one day
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-A00507-44
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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