Detection of Human Cytomegalovirus in the Saliva - Full Text View

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00815802

Purpose

Direct DNA amplification, viral isolation and specific antibody measurement in saliva

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

Condition
Cytomegalovirus

MedlinePlus related topics: Cytomegalovirus Infections

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

One week trial of saliva sampling for cytomegalovirus detection in day-care centers. [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Enrollment:	655
Study Start Date:	July 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	3 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

child aged from 3 month to 6 years in day care centers or in emergency department.

Criteria

Inclusion Criteria:

parents consent
child aged from 3months to 6 years
child in day care centers or emergency department

Exclusion Criteria:

Refuse of participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815802

Locations

France
Bactériologie-Virologie
Limoges, France, 87

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Sophie ALAIN, MD

University Hospital, Limoges

More Information

Study ID Numbers:	I07017
Study First Received:	December 29, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00815802
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Children in day care centers
cytomegalovirus excretion

Study placed in the following topic categories:

Virus Diseases
Cytomegalovirus Infections
DNA Virus Infections

Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 11, 2009