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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014