Prospective cohort study to assess the performance of tools to describe the Natural History of CytoMegaloVirus infection and transmission in FAMILIes with children attending daycare centers in France (CMV FAMILI study)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Feasibility analysis

  Method development or testing
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Cytomegalovirus infection

Population studied

• Short description of the study population:
  This study will include parents/caregivers (ages 18 to 49) of children attending participating day-care centers (DCCs) in France, as well as their children who are attending the DCC. Children with known congenital CMV infection and/or disease and parents of children with known congenital CMV infection and/or disease are excluded.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Estimated number of subjects:
  3000

Study design details

• Study design:
  This is a prospective, longitudinal cohort study in which participants are enrolled through DCCs in France. The study will include two sequential phases: a pilot phase and a main phase. Both phases will use the same overarching design, sample collection schedule, and recruitment framework.
• Main study objective:
  The primary objective of this study is to assess the performance of PCR-based case definition criteria for identifying primary CMV infection in parents/caregivers who are CMV-seronegative at baseline.
• Setting:
  This study will include parents/caregivers of children attending participating DCCs in France, as well as their children who are attending the DCC. The primary setting for the study is DCCs located within the catchment areas of participating local laboratories to ensure feasibility of longitudinal sample collection.
• Outcomes:
  The primary outcome of the study will be primary CMV infection in adults. Primary CMV infection is defined as seroconversion, i.e. appearance of CMV Immunoglobulin G (IgG) and/or Immunoglobulin M (IgM) antibodies, using a commercial serology assay or the Sponsor’s serology assay in parents/caregivers who were CMV-seronegative at baseline.
• Data analysis plan:
  All analyses will be descriptive or exploratory; no hypothesis testing is planned. Continuous variables will be summarized using mean, standard deviation, median, interquartile range, and range where appropriate. Categorical variables will be summarized using counts and percentages where appropriate. Time‑to‑event analyses will use Kaplan-Meier methods to estimate cumulative incidence where appropriate. Incidence rates will be calculated per 100 person‑years, with 95% confidence intervals. Analyses will be stratified by variables of interest (e.g., sex, age, household size) where appropriate. All analyses will be conducted using validated statistical software.