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Recruiting NCT06522880

NCT06522880 Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

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Clinical Trial Summary
NCT ID NCT06522880
Status Recruiting
Phase
Sponsor University of Massachusetts, Worcester
Condition Cytomegalovirus Infections
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2023-08-10
Primary Completion 2027-01-31

Eligibility & Interventions

Sex All sexes
Min Age 1 Day
Max Age 36 Months
Study Type OBSERVATIONAL
Interventions
CMV PCR on saliva

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 100 participants in total. It began in 2023-08-10 with a primary completion date of 2027-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria Children 1. 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. 2. 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 1. Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time. 2. 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 1. \>/= 37 months of age 2. State Department of Children and Families (DCF) custody Center Staff 1. Do not regularly (average \< 5 days per year) work inside the center 2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Contact & Investigator

Central Contact

Laura Gibson, MD

✉ laura.gibson@umassmed.edu

📞 5089813660

Principal Investigator

Laura Gibson, MD

PRINCIPAL INVESTIGATOR

UMass Chan Medical School

Frequently Asked Questions

Who can join the NCT06522880 clinical trial?

This trial is open to participants of all sexes, aged 1 Day or older, up to 36 Months, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06522880 currently recruiting?

Yes, NCT06522880 is actively recruiting participants. Contact the research team at laura.gibson@umassmed.edu for enrollment information.

Where is the NCT06522880 trial being conducted?

This trial is being conducted at Worcester, United States.

Who is sponsoring the NCT06522880 clinical trial?

NCT06522880 is sponsored by University of Massachusetts, Worcester. The principal investigator is Laura Gibson, MD at UMass Chan Medical School. The trial plans to enroll 100 participants.

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