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Detection of Human Cytomegalovirus in the Saliva (FcrèchMV)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00815802
First received: December 29, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition
Cytomegalovirus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

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

No publications provided

ClinicalTrials.gov Identifier: NCT00815802     History of Changes
Other Study ID Numbers: I07017
Study First Received: December 29, 2008
Last Updated: December 29, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Children in day care centers
cytomegalovirus excretion

ClinicalTrials.gov processed this record on May 16, 2013