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Microsporidiosis IntestinalNITAZO-SPORENCT05417815

Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

An observational study of Microsporidiosis Intestinal, run by University Hospital, Clermont-Ferrand at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (~70% of cases in immunocompromised patients). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Microsporidiosis Intestinal
How many people
80 participants
Where
24 sitesin 2 countries
Study dates
1 Apr 2022to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: SOT with microsporidiosis

Who may be able to join

  • With a diagnosis of intestinal infection caused by E. bieneusi between 01/01/2018 and 03/31/2022
  • having received treatment with nitazoxanide ("NITAZO" group), or fumagillin ("FUMA" group), or albendazole ("ABZ") or having received no specific treatment but having benefited from an adjustment of the doses of immunosuppressants ("IS" group)

Who cannot join

  • With a diagnosis of extraintestinal infection
  • With a diagnosis of infection by a species other than E. bieneusi

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

France23 sites

  • CHU Amiens

    Amiens

  • CHU Besançon

    Besançon

  • CHU Bordeaux

    Bordeaux

  • CHU Brest

    Brest

  • CHU Caen

    Caen

  • CHU clermont-ferrand

    Clermont-Ferrand, 63000

  • CHU Dijon

    Dijon

  • CHU Grenoble

    Grenoble

  • CHU Lille

    Lille

  • CHU Limoges

    Limoges

  • Hospices Civils de Lyon

    Lyon

  • AP-HM

    Marseille

  • CHU Nancy

    Nancy

  • AP-HP Hopital Bichat Claude-Bernard

    Paris

  • AP-HP Hopital Necker-Enfants Malades

    Paris

  • AP-HP Hopital Saint-Antoine

    Paris

  • AP-HP Hopitaux Universitaires Henri-Mondor

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Rouen

    Rouen

  • CHU Saint-Etienne

    Saint-Etienne

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse

    Toulouse

  • CHU Tours

    Tours

Other trials in France

Guadeloupe1 site

  • CHU Pointe-à-Pitre

    Pointe-à-Pitre

Other trials in Guadeloupe

About this study

Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (~70% of cases in immunocompromised patients). In this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species Enterocytozoon bieneusi being found in more than 95% of these cases. Reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. However, in some cases, specific treatment is necessary. The only molecule whose efficacy has been proven to date to treat infections caused by E. bieneusi is fumagillin (FLISINT®), however its production has been stopped for almost 2 years. Due to the therapeutic impasse, the use of nitazoxanide (ALINIA®) to treat E. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. It seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in SOT, for the treatment of intestinal microsporidiosis due to E. bieneusi.

Keywords
microsporidia, Enterocytozoon bieneusi, solid organ transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficiency by symptoms

    time to resolution of symptoms

    Measured: 1 year

  2. efficiency by parasitology

    parasitological negativation

    Measured: 1 year

  3. efficiency by relapses

    number of relapses

    Measured: 1 year

  4. tolerance of treatment

    duration of treatment

    Measured: 1 year

  5. tolerance with side effects

    side effects during treatment: value of platelets, liver enzymes, occurrence of drug interactions

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Apr 2022
  4. Study completion1 Jun 2022

Resources

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05417815
Sponsor's protocol ID
2022 POIRIER NITAZO-SPORE
Acronym
NITAZO-SPORE
Status last verified
May 2022
First submitted
2 Jun 2022
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garrouste C, Poirier P, Uro-Coste C, Iriart X, Kamar N, Bonhomme J, Calvar E, Le Gal S, Lanfranco L, Autier B, Rakoff L, Durieux MF, Danthu C, Morio F, Deltombe C, Moreno-Sabater A, Ouali N, Costa D, Bertrand D, Chesnay A, Gatault P, Rabodonirina M, Morelon E, Dumortier J, Sitterle E, Scemla A, Hamane S, Cachera L, Damiani C, Poulain C, L'Ollivier C, Moal V, Delhaes L, Kaminski H, Cateau E, Ecotiere L, Brunet J, Caillard S, Valot S, Tinel C, Argy N, Raimbourg Q, Robert MG, Noble J, Boignard A, Botterel F, Matignon M, Bellanger AP, Crepin T, Leroy J, Lionet A, Debourgogne A, Nicolas M, Claudeon J, Moniot M, Lambert C, Nourrisson C. Fumagillin Shortage: How to Treat Enterocytozoon bieneusi Microsporidiosis in Solid Organ Transplant Recipients in 2024? Transpl Int. 2024 Dec 12;37:13518. doi: 10.3389/ti.2024.13518. eCollection 2024.

    PubMed 39726674

Questions about this trial

What is this clinical trial studying?

An observational study of Microsporidiosis Intestinal, run by University Hospital, Clermont-Ferrand at 24 sites in 2 countries.

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 2 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Guadeloupe. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficiency by symptoms (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417815, which also lists 1 linked publication.

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 27 Jul 2022.

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