NCT02855463

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

5.2 years

First QC Date

August 1, 2016

Last Update Submit

August 3, 2016

Conditions

Keywords

Giant virusAmoeba

Outcome Measures

Primary Outcomes (1)

  • Number of children carriers in their digestive tract of giant viruses (and their virophages) associated with amoebae

    1 day

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patient aged \> 15.3 years;
  • Patient for whom informed consent is not signed by a parent or legal representative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Catherine GEINDRE

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 4, 2016

Study Start

July 1, 2011

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations