Clinical trial NCT05417815: Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis
Official title: Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microsporidiosis Intestinal
Keywords: microsporidia
Enterocytozoon bieneusi
solid organ transplant
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SOT with microsporidiosis

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.


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

Primary outcomes:
measure: efficiency by symptoms
timeFrame: 1 year
measure: efficiency by parasitology
timeFrame: 1 year
measure: efficiency by relapses
timeFrame: 1 year
measure: tolerance of treatment
timeFrame: 1 year
measure: tolerance with side effects
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: AP-HM
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: AP-HP Hopital Bichat Claude-Bernard
city: Paris
country: France
facility: AP-HP Hopital Necker-Enfants Malades
city: Paris
country: France
facility: AP-HP Hopital Saint-Antoine
city: Paris
country: France
facility: AP-HP Hopitaux Universitaires Henri-Mondor
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe-à-Pitre
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Philippe Poirier
role: STUDY_DIRECTOR
References: