Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

NCT ID: NCT05417815

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-06-01

Brief 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). 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.

Conditions

Microsporidiosis Intestinal

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Poirier

Role: STUDY_DIRECTOR

University Hospital, Clermont-Ferrand

Locations

CHU Amiens

Amiens, , France

CHU Besançon

Besançon, , France

CHU Bordeaux

Bordeaux, , France

CHU Brest

Brest, , France

CHU Caen

Caen, , France

CHU clermont-ferrand

Clermont-Ferrand, , France

CHU Dijon

Dijon, , France

CHU Grenoble

Grenoble, , France

CHU Lille

Lille, , France

CHU Limoges

Limoges, , France

Hospices Civils de Lyon

Lyon, , France

AP-HM

Marseille, , France

CHU Nancy

Nancy, , France

AP-HP Hopital Bichat Claude-Bernard

Paris, , France

AP-HP Hopital Necker-Enfants Malades

Paris, , France

AP-HP Hopital Saint-Antoine

Paris, , France

AP-HP Hopitaux Universitaires Henri-Mondor

Paris, , France

CHU Poitiers

Poitiers, , France

CHU Rouen

Rouen, , France

CHU Saint-Etienne

Saint-Etienne, , France

CHU Strasbourg

Strasbourg, , France

CHU Toulouse

Toulouse, , France

CHU Tours

Tours, , France

CHU Pointe-à-Pitre

Pointe-à-Pitre, , Guadeloupe

Countries

France; Guadeloupe

References

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.

Reference Type: DERIVED

PMID: 39726674 (View on PubMed)

Other Identifiers

2022 POIRIER NITAZO-SPORE

Identifier Type: -

Identifier Source: org_study_id