Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

NCT05417815 | Completed

• 1 other identifier: 2022 POIRIER NITAZO-SPORE
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 24

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

Keywords

microsporidia; Enterocytozoon bieneusi; solid organ transplant

Outcome Measures

Primary Outcomes (5)

• efficiency by symptoms

  time to resolution of symptoms

  1 year

• efficiency by parasitology

  parasitological negativation

  1 year

• efficiency by relapses

  number of relapses

  1 year

• tolerance of treatment

  duration of treatment

  1 year

• tolerance with side effects

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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SOT with microsporidiosis

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (24)

CHU Amiens

Amiens, France

Location

CHU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

CHU Caen

Caen, France

Location

CHU clermont-ferrand

Clermont-Ferrand, 63000, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

CHU Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

Hospices Civils de Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU Nancy

Nancy, France

Location

AP-HP Hopital Bichat Claude-Bernard

Paris, France

Location

AP-HP Hopital Necker-Enfants Malades

Paris, France

Location

AP-HP Hopital Saint-Antoine

Paris, France

Location

AP-HP Hopitaux Universitaires Henri-Mondor

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rouen

Rouen, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

CHU Pointe-à-Pitre

Pointe-à-Pitre, Guadeloupe

Location

Related Publications (1)

• 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.

  PMID: 39726674 DERIVED

Study Officials

• Philippe Poirier

  University Hospital, Clermont-Ferrand

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); FR (23)