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NCT01704222 Clinical Trial

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

Healthy Volunteers Clinical Trial

— CrèchMV  

Official title:
Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01704222
Other study ID # I07040 CrèchMV
Secondary ID
Status Completed
Phase N/A
First received October 8, 2012
Last updated October 31, 2013
Start date September 2009
Est. completion date September 2013

Study information
Verified date October 2012
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 2001
Est. completion date September 2013
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 6 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Bacteriology Limoges

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of viral shedding Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA. 1 day No
Secondary Evaluate the distribution of different genotypes of strains of CMV distribution by genotype strains found 1 day No
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