Microsporidiosis IntestinalCARMICNCT06986980
Intestinal Microsporidiosis in French Heart Transplant Recipients (CARMIC)
An observational study of Microsporidiosis Intestinal and Heart Transplant Infection, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microsporidiosis Intestinal, Heart Transplant Infection
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Heart transplant patients with microsporidiosis
Who may be able to join
- heart transplant patients diagnosed with intestinal microsporidiosis
- diagnosis made before December 31, 2024 in France (metropolitan France and overseas territories)
Who cannot join
- -patient opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Gabriel Montpied
Clermont-Ferrand, 63000
About this study
Official title: Intestinal Microsporidiosis in French Heart Transplant Recipients
The investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on microsporidiosis among heart transplant patients.
Read the 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.
- Keywords
- microsporidiosis, Enterocytozoon bieneusi, Encephalitozoon intestinalis, Encephalitozoon hellem, solid organ transplant, heart transplant
- Medical subject headings
- Microsporidiosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data: age
expressed in years old
Measured: 1 year
Demographic data: sex
choice between: male/female
Measured: 1 year
Time between transplant and microsporidiosis
expressed in days, or years if >365 days
Measured: 1 year
At diagnosis: number of days since the onset of symptoms
expressed in number of days
Measured: 1 year
Weight loss at diagnosis
expressed in kilogram or in percent (compared to usual weight of the patient)
Measured: 1 year
Dosage of immunosuppressants at diagnosis
Measured: 1 year
Time to stool negativation
expressed in number of days between onset of treatment and first negative PCR during follow-up
Measured: 1 year
Creatinine level in blood at Day 0 (diagnosis) and Month 3
expressed in µM
Measured: 3 months
Numeration of cells in blood: platelets, lymphocytes, neutrophils at Day 0 (diagnosis) and Month 3
expressed in Giga per litre
Measured: 3 months
Gammaglobulins in blood at diagnosis
expressed in gram per litre
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start5 May 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsporidiosis IntestinalStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986980
- Sponsor's protocol ID
- 2025 NOURRISSON GARROUSTE
- Acronym
- CARMIC
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microsporidiosis in French Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT06986980
- Acronym / sponsor ID
- CARMIC / 2025 NOURRISSON GARROUSTE
- Keywords
- microsporidiosis, Enterocytozoon bieneusi, Encephalitozoon intestinalis, Encephalitozoon hellem, solid organ transplant, heart transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Heart transplant patients with microsporidiosis
Key inclusion criteria (2 listed)
- heart transplant patients diagnosed with intestinal microsporidiosis
- diagnosis made before December 31, 2024 in France (metropolitan France and overseas territories)
Key exclusion criteria (1 listed)
- -patient opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microsporidiosis Intestinal and Heart Transplant Infection, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data: age (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.