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Intestinal Microsporidiosis in French Heart Transplant Recipients (CARMIC)

Intestinal Microsporidiosis in French Heart Transplant Recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06986980
Acronym
CARMIC
Enrollment
39
Registered
2025-05-23
Start date
2025-05-05
Completion date
2025-12-31
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Infection, Microsporidiosis Intestinal

Keywords

microsporidiosis, Enterocytozoon bieneusi, Encephalitozoon intestinalis, Encephalitozoon hellem, solid organ transplant, heart transplant

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Demographic data: age1 yearexpressed in years old
Demographic data: sex1 yearchoice between: male/female
Time between transplant and microsporidiosis1 yearexpressed in days, or years if \>365 days
At diagnosis: number of days since the onset of symptoms1 yearexpressed in number of days
Weight loss at diagnosis1 yearexpressed in kilogram or in percent (compared to usual weight of the patient)
Dosage of immunosuppressants at diagnosis1 year
Time to stool negativation1 yearexpressed 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 33 monthsexpressed in µM
Numeration of cells in blood: platelets, lymphocytes, neutrophils at Day 0 (diagnosis) and Month 33 monthsexpressed in Giga per litre
Gammaglobulins in blood at diagnosis1 yearexpressed in gram per litre

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026