Study of Giant Viruses of Amoebas Infections in Children Suffering From Gastroenteritis

Gastroenteritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855463
• Other study ID #: RC12_3755 - 1930
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 3, 2016
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Urielle DESALBRES
• Phone: 04 91 38 20 61
• Email: urielle.desalbres[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial origin or cellular proteins This project focuses on the detection and analysis of new viral agents (viruses and virophages giant amoeba environmental) and their involvement in human pathology.

The objectives of this study are observational: detect and document the presence of giant viruses and virophages of amoebae in the faeces of children presenting to the pediatric emergency reception service of the North Hospital in AP -HM with or without clinical evidence of gastroenteritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• Patient admitted in the Pediatric Emergency Service of Northern Hospital, Marseille, France

• Patient aged = 15.3 years, male or female;

• Patient for whom a microbiological exam should be performed during the clinical management, with or without a clinical diagnosis of gastroenteritis (ie including diarrhea which will be defined by the issuance of at least three molded or watery stools per day for more than 24 hours) at the time of the collection of stool;

• Patient for whom informed consent was read, understood, signed by a parent or legal representative.

Exclusion criteria

• Patient aged > 15.3 years;

• Patient for whom informed consent is not signed by a parent or legal representative.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children carriers in their digestive tract of giant viruses (and their virophages) associated with amoebae		1 day	Yes