An observational study in Streptococcus Pneumoniae Infection and Respiratory Syncytial Virus Infections, sponsored by Mackay Memorial Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Mackay Memorial Hospital · Observational
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.
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.
298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.
This study's planned enrollment of 240 is below the median of 810 across 43 observational studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The husband and wife with baby (aged less than 5 months) and with or without children (2-5)
The husband and wife with baby (aged less than 5 months), children (2-5), and grandparents aged \> 65 years old
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.
Time frame: 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.
Time frame: 2 years
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We will record and analyze the individual participant data by our study team only.
Start is estimated for Oct 2021; primary completion for Jul 2026, 57 months later.
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This study is not yet recruiting, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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