Intestinal Microsporidiosis in French Heart Transplant Recipients
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
