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

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.

Study Overview

• Status: Unknown
• Conditions: Gastroenteritis

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children admitted for gastroenteritis who need a microbiological exam to confirm diagnosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of children carriers in their digestive tract of giant viruses (and their virophages) associated with amoebae	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Giant virus; Amoeba
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: RC12_3755 - 1930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided