Healthy VolunteersCrèchMVNCT01704222
Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France
An observational study of Healthy Volunteers, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 2,001 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Refusal of parents (lack of consent)
- Refusal of the child according to his ability to understand
- Uninsured social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.
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.
Read the detailed description
Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.
- Conditions
- Healthy Volunteers
- Keywords
- Children, nursery, CMV, Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of viral shedding
Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.
Measured: 1 day
Secondary outcomes (1)
Evaluate the distribution of different genotypes of strains of CMV
distribution by genotype strains found
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie ALAIN, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704222
- Sponsor's protocol ID
- I07040 CrèchMV
- Acronym
- CrèchMV
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2012
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32068854
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.
- ClinicalTrials.gov ID
- NCT01704222
- Acronym / sponsor ID
- CrèchMV / I07040 CrèchMV
- Conditions
- Healthy Volunteers
- Keywords
- Children, nursery, CMV, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal of parents (lack of consent)
- Refusal of the child according to his ability to understand
- Uninsured social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of viral shedding
Time frame: 1 day
Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.
1 secondary outcome
Evaluate the distribution of different genotypes of strains of CMV
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Derived from this study: PubMed 32068854Alain 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie ALAIN, MD principal investigator
Limoges UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of viral shedding (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.