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Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05417815
Acronym
NITAZO-SPORE
Enrollment
80
Registered
2022-06-14
Start date
2022-04-01
Completion date
2022-06-01
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microsporidiosis Intestinal

Keywords

microsporidia, Enterocytozoon bieneusi, solid organ transplant

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficiency by symptoms1 yeartime to resolution of symptoms
efficiency by parasitology1 yearparasitological negativation
efficiency by relapses1 yearnumber of relapses
tolerance of treatment1 yearduration of treatment
tolerance with side effects1 yearside effects during treatment: value of platelets, liver enzymes, occurrence of drug interactions

Countries

France, Guadeloupe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026