Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis (NITAZO-SPORE)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Microsporidiosis Intestinal

Study type: Observational

Funder types: Other

Identifiers

NCT05417815

2022 POIRIER NITAZO-SPORE

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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