NCT06986980

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 17, 2025

Last Update Submit

June 27, 2025

Conditions

Microsporidiosis IntestinalHeart Transplant Infection

Keywords

microsporidiosisEnterocytozoon bieneusiEncephalitozoon intestinalisEncephalitozoon hellemsolid organ transplantheart transplant

Outcome Measures

Primary Outcomes (10)

  • Demographic data: age

    expressed in years old

    1 year

  • Demographic data: sex

    choice between: male/female

    1 year

  • Time between transplant and microsporidiosis

    expressed in days, or years if \>365 days

    1 year

  • At diagnosis: number of days since the onset of symptoms

    expressed in number of days

    1 year

  • Weight loss at diagnosis

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

    1 year

  • Dosage of immunosuppressants at diagnosis

    1 year

  • Time to stool negativation

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

    1 year

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

    expressed in µM

    3 months

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

    expressed in Giga per litre

    3 months

  • Gammaglobulins in blood at diagnosis

    expressed in gram per litre

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart transplant patients with microsporidiosis

You may qualify if:

  • heart transplant patients diagnosed with intestinal microsporidiosis
  • diagnosis made before December 31, 2024 in France (metropolitan France and overseas territories)

You may not qualify if:

  • patient opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Microsporidiosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 23, 2025

Study Start

May 5, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-04

Locations

FR(1)