Multicenter Cohort Study of Invasive Fungal Filamentous F... | NCT05150327

Studies
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

NCT05150327

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Fungal Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2021Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Sep 1, 2024Actual

First Submitted Date

Nov 25, 2021

First Submission Date that Met QC Criteria

Nov 25, 2021

First Posted Date

Dec 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François DANION, MD	Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D009181	Mycoses
D007153	Immunologic Deficiency Syndromes

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided