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NCT Number: NCT06986980

Intestinal Microsporidiosis in French Heart Transplant Recipients (CARMIC)

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

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Key information

Conditions

Microsporidiosis Intestinal Bacterial Infections and Mycoses Heart Transplant Infection Infections Microsporidiosis Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographic data: age

    Time frame: 1 year

    expressed in years old

  2. Demographic data: sex

    Time frame: 1 year

    choice between: male/female

  3. Time between transplant and microsporidiosis

    Time frame: 1 year

    expressed in days, or years if >365 days

  4. At diagnosis: number of days since the onset of symptoms

    Time frame: 1 year

    expressed in number of days

  5. Weight loss at diagnosis

    Time frame: 1 year

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

  6. Dosage of immunosuppressants at diagnosis

    Time frame: 1 year

  7. Time to stool negativation

    Time frame: 1 year

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

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

    Time frame: 3 months

    expressed in µM

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

    Time frame: 3 months

    expressed in Giga per litre

  10. Gammaglobulins in blood at diagnosis

    Time frame: 1 year

    expressed in gram per litre

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Intestinal Microsporidiosis in French Heart Transplant Recipients

Acronym: CARMIC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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