Study on household Transmission using sAliva RSV tests (STARS-I) - a pilot study

Study on household Transmission using sAliva RSV tests (STARS-I) - a pilot study - STARS-I

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56918

Enrollment

300

Registered

2024-07-24

Start date

2024-09-16

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory tract infection RSV infection

Interventions

None listed

Eligibility

Age

No minimum to 99 Years

Inclusion criteria

Inclusion criteria: - Be part of a household with at least 1 child 60 years) will be included when visiting the household at least once a week for at least 4 hours (pe regular babysitting while parents go to work) during the whole study period.

Exclusion criteria

Exclusion criteria: - Clinically significant primary or secondary immunodeficiency. - Having a household member who does not participate or who intend to be away from the household for >1 month during the study period. - Not able to communicate in Dutch or English. - Any medical condition for which it is foreseen that the household member will be hospitalized >7 days during the study period.

Design outcomes

Primary

Measure	Time frame
The primary outcomes are the probability of introduction of RSV into the household by type of household member and probability of transmission between household members. To determine the probability of types of household members to introduce RSV in the household, we will identify the index case of each household RSV episode as the first household member to be infected. To determine the probability of transmission between household members, we will reconstruct the chain of transmission using RSV testing results, information from the questionnaires and a chain binomial model. To capture all RSV infections, household members will be asked to take saliva samples twice per week of follow-up. The presence of RSV in samples will be ascertained by PCR.	—

Measure

Time frame

The primary outcomes are the probability of introduction of RSV into the household by type of household member and probability of transmission between household members. To determine the probability of types of household members to introduce RSV in the household, we will identify the index case of each household RSV episode as the first household member to be infected. To determine the probability of transmission between household members, we will reconstruct the chain of transmission using RSV testing results, information from the questionnaires and a chain binomial model. To capture all RSV infections, household members will be asked to take saliva samples twice per week of follow-up. The presence of RSV in samples will be ascertained by PCR.

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Secondary

Measure	Time frame
1. The annual incidence of RSV infection in households with young children 2. The proportion of asymptomatic RSV cases among all RSV infections in adults and children 3. The rate of secondary RSV infections within the same household 4. The duration of RSV positivity 5. The delay between the first positive sample of two generations of cases 6. The secondary attack rate in grandparents who visit the household on a weekly base	—

Measure

Time frame

1. The annual incidence of RSV infection in households with young children 2. The proportion of asymptomatic RSV cases among all RSV infections in adults and children 3. The rate of secondary RSV infections within the same household 4. The duration of RSV positivity 5. The delay between the first positive sample of two generations of cases 6. The secondary attack rate in grandparents who visit the household on a weekly base

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Countries

Netherlands

Outcome results