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

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01704222
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-02
• Status Verified: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Study Completion: 2013-09
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2001

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of viral shedding	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

Name	Time	Method
Evaluate the distribution of different genotypes of strains of CMV	1 day	distribution by genotype strains found

Trial Locations

Locations (1)

Bacteriology; 🇫🇷 Limoges, France