Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

Completed

• Conditions: Microsporidiosis Intestinal

• Registration Number: NCT05417815
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-04-01
• Status Verified: 2022-05
• Study Completion: 2022-06-01
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficiency by symptoms	1 year	time to resolution of symptoms
tolerance of treatment	1 year	duration of treatment
efficiency by parasitology	1 year	parasitological negativation
efficiency by relapses	1 year	number of relapses
tolerance with side effects	1 year	side effects during treatment: value of platelets, liver enzymes, occurrence of drug interactions

Trial Locations

Locations (24)

AP-HM; 🇫🇷 Marseille, France

AP-HP Hopitaux Universitaires Henri-Mondor; 🇫🇷 Paris, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Brest; 🇫🇷 Brest, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Amiens; 🇫🇷 Amiens, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU Caen; 🇫🇷 Caen, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Lille; 🇫🇷 Lille, France

CHU Poitiers; 🇫🇷 Poitiers, France

AP-HP Hopital Bichat Claude-Bernard; 🇫🇷 Paris, France

CHU Grenoble; 🇫🇷 Grenoble, France

AP-HP Hopital Necker-Enfants Malades; 🇫🇷 Paris, France

CHU Tours; 🇫🇷 Tours, France

CHU Pointe-à-Pitre; 🇬🇵 Pointe-à-Pitre, Guadeloupe

AP-HP Hopital Saint-Antoine; 🇫🇷 Paris, France