CytomegalovirusFcrèchMVNCT00815802
Detection of Human Cytomegalovirus in the Saliva
An observational study of Cytomegalovirus, run by University Hospital, Limoges at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus
- How many people
- 655 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to 19 Sep 2014
- 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 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: child aged from 3 month to 6 years in day care centers or in emergency department.
Who may be able to join
- parents consent
- child aged from 3months to 6 years
- child in day care centers or emergency department
Who cannot join
- Refuse of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cytomegalovirus
- Keywords
- Children in day care centers, cytomegalovirus excretion
What is being measured
The primary outcome is the main question the study is designed to answer.
One week trial of saliva sampling for cytomegalovirus detection in day-care centers.
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startJul 2007
- Primary completion19 Sep 2014
- Study completion19 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytomegalovirusStudies 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
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Sophie ALAIN, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815802
- Sponsor's protocol ID
- I07017
- Acronym
- FcrèchMV
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-old Children in Day Care Centers : a Pilot Study.
- ClinicalTrials.gov ID
- NCT00815802
- Acronym / sponsor ID
- FcrèchMV / I07017
- Conditions
- Cytomegalovirus
- Keywords
- Children in day care centers, cytomegalovirus excretion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- 19 Sep 2014 (actual)
- Study completion
- 19 Sep 2014
- First posted
- 30 Dec 2008 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- child aged from 3 month to 6 years in day care centers or in emergency department.
Key inclusion criteria (3 listed)
- parents consent
- child aged from 3months to 6 years
- child in day care centers or emergency department
Key exclusion criteria (1 listed)
- Refuse of participation
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
One week trial of saliva sampling for cytomegalovirus detection in day-care centers.
1 secondary outcome
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
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 9 Jun 2026.
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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
University Hospital, Limoges
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 Cytomegalovirus, 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 3 inclusion and 1 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 9 Jun 2026. 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?
One week trial of saliva sampling for cytomegalovirus detection in day-care centers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.