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Recruiting NCT06522880

Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

— Observational Cytomegalovirus Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMV PCR on saliva.
Who it may be relevant to
Registry conditions: Cytomegalovirus Infections. Basic parameters: 1 Day — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study: An Observational Study to Evaluate CMV Transmission and Immune Correlates of Viral Shedding Among Young Children in Early Education and Care Settings

Overview

The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.

Interventions

  • Diagnostic test CMV PCR on saliva
    Observational study to measure prevalence of CMV shedding by saliva PCR

Primary outcome measures

  • Prevalence of CMV shedding [Time frame: Stage I up to 2 years]

Eligibility criteria

Inclusion criteria

Children

  • All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.
  • Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home

Center Staff

  • Individuals who regularly (average >/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
  • Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home

Exclusion criteria

Children

  • >/= 37 months of age
  • State Department of Children and Families (DCF) custody

Center Staff

  • Do not regularly (average < 5 days per year) work inside the center
  • Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • UMass Chan Medical School — Worcester

Identifiers

NCT: NCT06522880 · IRB 00000521

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗