Non Primary HCMV Infection: Natural History and Immune Response (NCT06337955) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Non Primary HCMV Infection: Natural History and Immune Response
Italy204 participantsStarted 2017-06-06
Plain-language summary
The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.
Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).
To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (≥18 years of age) HCMV IgG-positive, breast feeding\* woman.
* Willingness to enroll the infant in a public or private day care facility with at least 5 attendees at ≤ 12 months of age.
* Willingness to participate in the study.
* In case of foreign origin, language skills sufficient to understand information material and give informed consent.
* Written informed consent. \* Breast feeding not required in case of availability of HCMV DNA-positive samples from the mother and/or fetus and/or newborn.
Exclusion Criteria:
* Congenital or acquired immunodeficiency
* Immunosuppressive therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HCMV non-primary infection (reinfection or reactivation).
Timeframe: T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
Trial details
NCT IDNCT06337955
SponsorFondazione IRCCS Policlinico San Matteo di Pavia