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NCT00815802 Clinical Trial

Detection of Human Cytomegalovirus in the Saliva

Cytomegalovirus Clinical Trial

— FcrèchMV  

Official title:
Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00815802
Other study ID # I07017
Secondary ID
Status Completed
Phase N/A
First received December 29, 2008
Last updated December 29, 2008
Start date July 2007

Study information
Verified date December 2008
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

1. From children in day care centers (samples collection will take place during a single week)

2. From children coming at the emergency department of our hospital during a three months period.

Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Description:

Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

Recruitment information / eligibility
Status Completed
Enrollment 655
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 6 Years
Eligibility Inclusion Criteria:

- parents consent

- child aged from 3months to 6 years

- child in day care centers or emergency department

Exclusion Criteria:

- Refuse of participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Bactériologie-Virologie 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 One week trial of saliva sampling for cytomegalovirus detection in day-care centers. No
Secondary Percentage of chidrens with CMV excretion among those coming at the Emergency department of Limoges teacher Hospital (CHU). Validation of the process from samples collection to interpretation of results No
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