NCT01704222

Brief Summary

Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2012

Enrollment Period

2.4 years

First QC Date

October 8, 2012

Last Update Submit

October 31, 2013

Conditions

Healthy Volunteers

Keywords

ChildrennurseryCMVInfection

Outcome Measures

Primary Outcomes (1)

  • Identification of viral shedding

    Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.

    1 day

Secondary Outcomes (1)

  • Evaluate the distribution of different genotypes of strains of CMV

    1 day

Study Arms (1)

Child in nursery

Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

You may qualify if:

  • Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

You may not qualify if:

  • Refusal of parents (lack of consent)
  • Refusal of the child according to his ability to understand
  • Uninsured social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bacteriology

Limoges, 87042, France

Location

Related Publications (1)

  • Alain S, Garnier-Geoffroy F, Labrunie A, Montane A, Marin B, Gatet M, Grosjean J, Dufour V, Saugeras M, Postil D, Hantz S. Cytomegalovirus (CMV) Shedding in French Day-Care Centers: A Nationwide Study of Epidemiology, Risk Factors, Centers' Practices, and Parents' Awareness of CMV. J Pediatric Infect Dis Soc. 2020 Dec 31;9(6):686-694. doi: 10.1093/jpids/piz097.

    PMID: 32068854DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Infections

Study Officials

  • Sophie ALAIN, MD

    Limoges UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

September 1, 2013

Last Updated

November 1, 2013

Record last verified: 2012-10

Locations

FR(1)