Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus

NCT05017519 | Not Yet Recruiting

• 1 other identifier: MSD MISP 60284
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

This household-based prospective cohort study aims to stablish the household transmission of Respiratory syncytial virus and S. pneumoniae especially in the elderly and infants/children as well as inter-relationship between S. pneumoniae and Respiratory syncytial virus.

Conditions

Streptococcus Pneumoniae Infection; Respiratory Syncytial Virus Infections

Keywords

Streptococcus Pneumoniae; Respiratory Syncytial Virus; household-based

Outcome Measures

Primary Outcomes (2)

• Household transmission of Streptococcus pneumoniae and Respiratory syncytial virus

  The primary endpoint is the Streptococcus pneumoniae and Respiratory syncytial virus isolation rates in children and their household contacts of different family type.

  2 years

• The serotype of Streptococcus pneumoniae and Respiratory syncytial virus in post-Prevenar 13 era

  The secondary endpoint is the serotype of Streptococcus pneumoniae and Respiratory syncytial virus in post-Prevenar 13 era.

  2 years

Study Arms (2)

Nuclear family type

The husband and wife with baby (aged less than 5 months) and with or without children (2-5)

Extended family type (three-generation family)

The husband and wife with baby (aged less than 5 months), children (2-5), and grandparents aged \> 65 years old

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A household-based prospective cohort study will invite 240 households, having a baby who is discharged from MacKay children's Hospital. The households will be classified into nuclear family type and extended family type. The "Nuclear family type" is defined as husband and wife with baby (aged less than 5 months) and with or without children (2-5) and the "Extended family type" (three-generation family) is defined as husband and wife with baby (aged less than 5 months), children (2-5), and grandparents aged \> 65 years old.

You may qualify if:

• Indicator case: Babies under 5 months of age were born in Mackay Children's Hospital and had no acute respiratory infection-like symptoms that required medical intervention when they agreed to participate in the trial.
• Family members: family members living with the Indicator case, including 2-5 years old siblings, parents and grandparents over 65 years old.
• Willing to sign the informed consent form and agree to join the official LINE account to receive research tracking.

You may not qualify if:

• Babies older than 5 months
• Co-morbid medical conditions of the baby such as chronic lung disease, cyanotic congenital heart disease, neuromuscular disease and a primary immunodeficiency.
• Family members who do not live with the Indicator case
• Family with grandparents younger than 65 years old
• Someone living with family members refuses to participate in the research.
• Unwilling to sign informed consent form or refuse to join the official LINE account to receive tracking.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

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Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal or throat swab and urine sample

MeSH Terms

Conditions

Pneumococcal Infections; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Hsin Chi, Doctor

  Mackay Children's Hospital in Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin Chi, Doctor

CONTACT

+886 975835388; chi4531@gmail.com

Nan-Chang Chiu, Doctor

CONTACT

+886 975835382; ncc88@mmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share