- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815802
Detection of Human Cytomegalovirus in the Saliva (FcrèchMV)
December 29, 2008 updated by: University Hospital, Limoges
Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
655
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Limoges, France, 87
- Bactériologie-Virologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
child aged from 3 month to 6 years in day care centers or in emergency department.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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One week trial of saliva sampling for cytomegalovirus detection in day-care centers.
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sophie ALAIN, MD, University Hospital, Limoges
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Registration Dates
First Submitted
December 29, 2008
First Submitted That Met QC Criteria
December 29, 2008
First Posted (Estimate)
December 30, 2008
Study Record Updates
Last Update Posted (Estimate)
December 30, 2008
Last Update Submitted That Met QC Criteria
December 29, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- I07017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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