NCT05150327

Brief Summary

Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

November 25, 2021

Last Update Submit

September 16, 2024

Conditions

Fungal Infection

Keywords

Fungal InfectionImmunodeficiencyFungal filamentousLiver transplantOrgan transplant

Outcome Measures

Primary Outcomes (1)

  • Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients.

    Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021

You may qualify if:

  • Age: from birth
  • Subject with a liver transplant in one of the centers participating in the study
  • Invasive fungal infection with filamentous fungus between 2007-2021
  • Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:
  • Invasive aspergillosis
  • Mucormycosis
  • Fusariosis
  • Scedosporiosis
  • Other infection with filamentous fungus
  • Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.

You may not qualify if:

  • Subject or (legal representative for minors) who has expressed his opposition to participating in the study
  • Subject not with a liver transplant
  • Subject under guardianship, curatorship or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

MycosesImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsImmune System Diseases

Study Officials

  • François DANION, MD

    Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 9, 2021

Study Start

October 29, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

FR(1)