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Clinical Trials/NCT06986980
NCT06986980RecruitingNot Applicable

Intestinal Microsporidiosis in French Heart Transplant Recipients

University Hospital, Clermont-Ferrand1 site in 1 country39 target enrollmentStarted: May 5, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
39
Locations
1
Primary Endpoint
Demographic data: age

Study Overview

Brief Summary

The investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on microsporidiosis among heart transplant patients.

Detailed Description

Microsporidia constitute a large family of intracellular eukaryotes infecting a wide range of hosts, ranging from insects to mammals and birds. Within this group, some species are responsible for intestinal syndromes manifested by abundant watery diarrhea, which can be particularly severe in immunocompromised individuals. In the 1980s, HIV-positive patients at the AIDS stage represented the primary population at risk. Nowadays, the most frequently affected patients among immunocompromised individuals are solid organ transplant recipients, for whom the management of this infection can be challenging. A neglected pathology until a few years ago, epidemiological data describing intestinal microsporidiosis in solid organ transplant recipients are scarce. The invesigators previously published the first data in kidney and liver transplant recipients. Here the investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on heart transplant patients.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •heart transplant patients diagnosed with intestinal microsporidiosis
  • •diagnosis made before December 31, 2024 in France (metropolitan France and overseas territories)

Exclusion Criteria

  • •patient opposition

Outcomes

Primary Outcomes

Demographic data: age

Time Frame: 1 year

expressed in years old

Demographic data: sex

Time Frame: 1 year

choice between: male/female

Time between transplant and microsporidiosis

Time Frame: 1 year

expressed in days, or years if \>365 days

At diagnosis: number of days since the onset of symptoms

Time Frame: 1 year

expressed in number of days

Weight loss at diagnosis

Time Frame: 1 year

expressed in kilogram or in percent (compared to usual weight of the patient)

Dosage of immunosuppressants at diagnosis

Time Frame: 1 year

Time to stool negativation

Time Frame: 1 year

expressed in number of days between onset of treatment and first negative PCR during follow-up

Creatinine level in blood at Day 0 (diagnosis) and Month 3

Time Frame: 3 months

expressed in µM

Numeration of cells in blood: platelets, lymphocytes, neutrophils at Day 0 (diagnosis) and Month 3

Time Frame: 3 months

expressed in Giga per litre

Gammaglobulins in blood at diagnosis

Time Frame: 1 year

expressed in gram per litre

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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