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Completed

NCT Number: NCT05417815

Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

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.

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Key information

Conditions

Microsporidiosis Intestinal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. efficiency by symptoms

    Time frame: 1 year

    time to resolution of symptoms

  2. efficiency by parasitology

    Time frame: 1 year

    parasitological negativation

  3. efficiency by relapses

    Time frame: 1 year

    number of relapses

  4. tolerance of treatment

    Time frame: 1 year

    duration of treatment

  5. tolerance with side effects

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: NITAZO-SPORE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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