Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

A household-based prospective cohort study will be conducted from 2021 to 2025 in northern Taiwan. We 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. We will initially complete an enrollment form to collect baseline data, including patient demographics, prior medical history, season when discharge, neonatal course and households. A LINE-based management will be done weekly by study team to see if there are any respiratory symptoms in household. In addition to the monthly physician weekly LINE response, the research nurse will contact the parents or legal guardians by telephone monthly for the 24 months to obtain data on changes in baseline information, and specific facts regarding possible respiratory infections after the last contact. If the households present with respiratory symptoms, the visit will be arranged as early as possible. When they presenting to the emergency department, outpatient clinic, or inpatient ward, the urine will be collected for the serotype-specific urinary antigen detection (SSUAD) assays and the nasopharyngeal or throat swab for polymerase chain reaction will be performed to study serotype of S. pneumoniae and Respiratory syncytial virus subgroup. If the subjects who have clinical syndromes suggestive of pneumonia or bronchopneumonia, they will be asked to participate in the further study along with their household family members. Nasopharyngeal aspiration, urine, blood, and induced sputum will be collected for cultures, polymerase chain reaction and serological test. Clinical manifestations, disease course, and outcomes will be recorded. Family members in the same household will asked to undergo screening with a nasopharyngeal or throat swab and urine sample. We will trace back 2-week contact history of children in nuclear family who get Respiratory syncytial virus or pneumococcal infections, especially focus on other family members. The data will be further analyzed to evaluate the influence of short period and long period contact. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05017519
Study type Observational [Patient Registry]
Source Mackay Memorial Hospital
Contact Hsin Chi, Doctor
Phone +886 975835388
Email chi4531@gmail.com
Status Not yet recruiting
Phase
Start date October 1, 2021
Completion date July 31, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Completed NCT04090658 - A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults Phase 1
Completed NCT04231968 - A Study of AK0529 in Chinese Infants Hospitalized With RSV Phase 3
Completed NCT03227029 - Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Terminated NCT02948127 - Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT02873286 - RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults Phase 2
Withdrawn NCT02864628 - RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults. Phase 1
Completed NCT02237209 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02040831 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02247726 - RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. Phase 2
Completed NCT01915394 - Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial) N/A
Completed NCT01355016 - A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers Phase 1
Completed NCT00232635 - A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT Phase 2
Completed NCT01155193 - Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Not yet recruiting NCT06083623 - A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Phase 2/Phase 3
Terminated NCT02890381 - Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Active, not recruiting NCT03422237 - Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT03674177 - A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women Phase 1
Completed NCT01968083 - Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1