Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

NCT07788417 | Not Yet Recruiting

• 1 other identifier: 2026-A00507-44
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Transplantation Infection; Pulmonary Transplantation

Outcome Measures

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

  single self-administered questionnaire completed at enrolment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (8)

Groupe Hospitalier Paris Saint-Joseph

Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France

Location

Hôpital Haut-Lévêque-Pessac, Bordeaux

Bordeaux, France

Location

Hôpital Louis Pradel - Lyon

Lyon, France

Location

Hôpital Nord - Marseille

Marseille, France

Location

Hôpital Nord Saint-Herblain- Nantes

Nantes, France

Location

Hôpital Bichat

Paris, France

Location

CHRU Strasbourg

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

Central Study Contacts

Benoît PILMIS;, MD

CONTACT

01.44.12.78.20; bpilmis@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

FR (8)