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Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France (CrèchMV)

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ClinicalTrials.gov Identifier: NCT01704222
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Condition or disease
Healthy Volunteers

Detailed Description:
Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

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Study Type : Observational
Actual Enrollment : 2001 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.
Study Start Date : September 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : September 2013

Group/Cohort
Child in nursery
Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.



Primary Outcome Measures :
  1. Identification of viral shedding [ Time Frame: 1 day ]
    Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.


Secondary Outcome Measures :
  1. Evaluate the distribution of different genotypes of strains of CMV [ Time Frame: 1 day ]
    distribution by genotype strains found


Biospecimen Retention:   Samples With DNA
Direct DNA amplification, viral isolation and specific antibody measurement in saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.
Criteria

Inclusion Criteria:

  • Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

Exclusion Criteria:

  • Refusal of parents (lack of consent)
  • Refusal of the child according to his ability to understand
  • Uninsured social security

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704222


Locations
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France
Bacteriology
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Sophie ALAIN, MD Limoges UH

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01704222     History of Changes
Other Study ID Numbers: I07040 CrèchMV
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2012
Keywords provided by University Hospital, Limoges:
Children
nursery
CMV
Infection