Intestinal Microsporidiosis in French Heart Transplant Recipients (CARMIC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Microsporidiosis Intestinal, Heart Transplant Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intestinal Microsporidiosis in French Heart Transplant Recipients
Overview
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.
Primary outcome measures
- Demographic data: age [Time frame: 1 year]
- Demographic data: sex [Time frame: 1 year]
- Time between transplant and microsporidiosis [Time frame: 1 year]
- At diagnosis: number of days since the onset of symptoms [Time frame: 1 year]
- Weight loss at diagnosis [Time frame: 1 year]
- Dosage of immunosuppressants at diagnosis [Time frame: 1 year]
- Time to stool negativation [Time frame: 1 year]
- Creatinine level in blood at Day 0 (diagnosis) and Month 3 [Time frame: 3 months]
- Numeration of cells in blood: platelets, lymphocytes, neutrophils at Day 0 (diagnosis) and Month 3 [Time frame: 3 months]
- Gammaglobulins in blood at diagnosis [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Gabriel Montpied — Clermont-Ferrand
Identifiers
NCT: NCT06986980 · 2025 NOURRISSON GARROUSTE