Streptococcus Pneumoniae InfectionNCT05017519
Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus
An observational study of Streptococcus Pneumoniae Infection and Respiratory Syncytial Virus Infections, run by Mackay Memorial Hospital.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infection, Respiratory Syncytial Virus Infections
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiology and Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus in Children and Elderly: a Household-based Prospective Cohort Study
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.
Read the detailed 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.
- Keywords
- Streptococcus Pneumoniae, Respiratory Syncytial Virus, household-based
- Medical subject headings
- Pneumococcal Infections, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Streptococcus Pneumoniae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Hsin Chi, Mackay Memorial Hospital
- Investigators
- Hsin Chi, Doctor, Principal investigator, Mackay Children's Hospital in Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017519
- Sponsor's protocol ID
- MSD MISP 60284
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will record and analyze the individual participant data by our study team only.
Publications
Huang YC, Lin CF, Ting PJ, Tang TH, Huang FL, Chao HJ, Wang CL, Chen PY. Respiratory pathogens - Some altered antibiotic susceptibility after implementation of pneumococcus vaccine and antibiotic control strategies. J Microbiol Immunol Infect. 2020 Oct;53(5):682-689. doi: 10.1016/j.jmii.2019.08.015. Epub 2019 Oct 18.
PubMed 31859164Lu CY, Chiang CS, Chiu CH, Wang ET, Chen YY, Yao SM, Chang LY, Huang LM, Lin TY, Chou JH. Successful Control of Streptococcus pneumoniae 19A Replacement With a Catch-up Primary Vaccination Program in Taiwan. Clin Infect Dis. 2019 Oct 15;69(9):1581-1587. doi: 10.1093/cid/ciy1127.
PubMed 30923808Feikin DR, Kagucia EW, Loo JD, Link-Gelles R, Puhan MA, Cherian T, Levine OS, Whitney CG, O'Brien KL, Moore MR; Serotype Replacement Study Group. Serotype-specific changes in invasive pneumococcal disease after pneumococcal conjugate vaccine introduction: a pooled analysis of multiple surveillance sites. PLoS Med. 2013;10(9):e1001517. doi: 10.1371/journal.pmed.1001517. Epub 2013 Sep 24.
PubMed 24086113Chi HC, Hsieh YC, Tsai MH, Lee CH, Kuo KC, Huang CT, Huang YC. Impact of pneumococcal conjugate vaccine in children on the serotypic epidemiology of adult invasive pneumococcal diseases in Taiwan. J Microbiol Immunol Infect. 2018 Jun;51(3):332-336. doi: 10.1016/j.jmii.2016.08.009. Epub 2016 Dec 18.
PubMed 28082066Ladhani SN, Collins S, Djennad A, Sheppard CL, Borrow R, Fry NK, Andrews NJ, Miller E, Ramsay ME. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. Lancet Infect Dis. 2018 Apr;18(4):441-451. doi: 10.1016/S1473-3099(18)30052-5. Epub 2018 Jan 26.
PubMed 29395999Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
PubMed 19196675Obando-Pacheco P, Justicia-Grande AJ, Rivero-Calle I, Rodriguez-Tenreiro C, Sly P, Ramilo O, Mejias A, Baraldi E, Papadopoulos NG, Nair H, Nunes MC, Kragten-Tabatabaie L, Heikkinen T, Greenough A, Stein RT, Manzoni P, Bont L, Martinon-Torres F. Respiratory Syncytial Virus Seasonality: A Global Overview. J Infect Dis. 2018 Apr 11;217(9):1356-1364. doi: 10.1093/infdis/jiy056.
PubMed 29390105Lin CY, Hwang D, Chiu NC, Weng LC, Liu HF, Mu JJ, Liu CP, Chi H. Increased Detection of Viruses in Children with Respiratory Tract Infection Using PCR. Int J Environ Res Public Health. 2020 Jan 15;17(2):564. doi: 10.3390/ijerph17020564.
PubMed 31952364Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019 Aug 31;394(10200):757-779. doi: 10.1016/S0140-6736(19)30721-4. Epub 2019 Jun 27.
PubMed 31257127Wolf DG, Greenberg D, Shemer-Avni Y, Givon-Lavi N, Bar-Ziv J, Dagan R. Association of human metapneumovirus with radiologically diagnosed community-acquired alveolar pneumonia in young children. J Pediatr. 2010 Jan;156(1):115-20. doi: 10.1016/j.jpeds.2009.07.014.
PubMed 19782998Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.
PubMed 25714161Chiu NC, Lin HY, Hsu CH, Huang FY, Lee KS, Chi H. Epidemiological and microbiological characteristics of culture-proven acute otitis media in Taiwanese children. J Formos Med Assoc. 2012 Oct;111(10):536-41. doi: 10.1016/j.jfma.2011.07.015. Epub 2012 Mar 13.
PubMed 23089688Kung YH, Chiu NC, Lee KS, Chang L, Huang DT, Huang FY, Hsieh YC, Huang LM, Chi H. Bacterial etiology of acute otitis media in the era prior to universal pneumococcal vaccination in Taiwanese children. J Microbiol Immunol Infect. 2014 Jun;47(3):239-44. doi: 10.1016/j.jmii.2013.08.016. Epub 2013 Sep 27.
PubMed 24080520Patel JA, Nguyen DT, Revai K, Chonmaitree T. Role of respiratory syncytial virus in acute otitis media: implications for vaccine development. Vaccine. 2007 Feb 19;25(9):1683-9. doi: 10.1016/j.vaccine.2006.10.045. Epub 2006 Nov 9.
PubMed 17156899de Steenhuijsen Piters WA, Heinonen S, Hasrat R, Bunsow E, Smith B, Suarez-Arrabal MC, Chaussabel D, Cohen DM, Sanders EA, Ramilo O, Bogaert D, Mejias A. Nasopharyngeal Microbiota, Host Transcriptome, and Disease Severity in Children with Respiratory Syncytial Virus Infection. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1104-1115. doi: 10.1164/rccm.201602-0220OC.
PubMed 27135599
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus in Children and Elderly: a Household-based Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05017519
- Acronym / sponsor ID
- MSD MISP 60284
- Keywords
- Streptococcus Pneumoniae, Respiratory Syncytial Virus, household-based
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Household transmission of Streptococcus pneumoniae and Respiratory syncytial virus
Time frame: 2 years
The primary endpoint is the Streptococcus pneumoniae and Respiratory syncytial virus isolation rates in children and their household contacts of different family type.
The serotype of Streptococcus pneumoniae and Respiratory syncytial virus in post-Prevenar 13 era
Time frame: 2 years
The secondary endpoint is the serotype of Streptococcus pneumoniae and Respiratory syncytial virus in post-Prevenar 13 era.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Results publication: PubMed 31859164Huang YC, Lin CF, Ting PJ, Tang TH, Huang FL, Chao HJ, Wang CL, Chen PY. Respiratory pathogens - Some altered antibiotic susceptibility after implementation of pneumococcus vaccine and antibiotic control strategies. J Microbiol Immunol Infect. 2020 Oct;53(5):682-689. doi: 10.1016/j.jmii.2019.08.015. Epub 2019 Oct 18.
- Results publication: PubMed 30923808Lu CY, Chiang CS, Chiu CH, Wang ET, Chen YY, Yao SM, Chang LY, Huang LM, Lin TY, Chou JH. Successful Control of Streptococcus pneumoniae 19A Replacement With a Catch-up Primary Vaccination Program in Taiwan. Clin Infect Dis. 2019 Oct 15;69(9):1581-1587. doi: 10.1093/cid/ciy1127.
- Results publication: PubMed 24086113Feikin DR, Kagucia EW, Loo JD, Link-Gelles R, Puhan MA, Cherian T, Levine OS, Whitney CG, O'Brien KL, Moore MR; Serotype Replacement Study Group. Serotype-specific changes in invasive pneumococcal disease after pneumococcal conjugate vaccine introduction: a pooled analysis of multiple surveillance sites. PLoS Med. 2013;10(9):e1001517. doi: 10.1371/journal.pmed.1001517. Epub 2013 Sep 24.
- Results publication: PubMed 28082066Chi HC, Hsieh YC, Tsai MH, Lee CH, Kuo KC, Huang CT, Huang YC. Impact of pneumococcal conjugate vaccine in children on the serotypic epidemiology of adult invasive pneumococcal diseases in Taiwan. J Microbiol Immunol Infect. 2018 Jun;51(3):332-336. doi: 10.1016/j.jmii.2016.08.009. Epub 2016 Dec 18.
- Results publication: PubMed 29395999Ladhani SN, Collins S, Djennad A, Sheppard CL, Borrow R, Fry NK, Andrews NJ, Miller E, Ramsay ME. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. Lancet Infect Dis. 2018 Apr;18(4):441-451. doi: 10.1016/S1473-3099(18)30052-5. Epub 2018 Jan 26.
- Results publication: PubMed 19196675Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
- Results publication: PubMed 29390105Obando-Pacheco P, Justicia-Grande AJ, Rivero-Calle I, Rodriguez-Tenreiro C, Sly P, Ramilo O, Mejias A, Baraldi E, Papadopoulos NG, Nair H, Nunes MC, Kragten-Tabatabaie L, Heikkinen T, Greenough A, Stein RT, Manzoni P, Bont L, Martinon-Torres F. Respiratory Syncytial Virus Seasonality: A Global Overview. J Infect Dis. 2018 Apr 11;217(9):1356-1364. doi: 10.1093/infdis/jiy056.
- Results publication: PubMed 31952364Lin CY, Hwang D, Chiu NC, Weng LC, Liu HF, Mu JJ, Liu CP, Chi H. Increased Detection of Viruses in Children with Respiratory Tract Infection Using PCR. Int J Environ Res Public Health. 2020 Jan 15;17(2):564. doi: 10.3390/ijerph17020564.
- Results publication: PubMed 31257127Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019 Aug 31;394(10200):757-779. doi: 10.1016/S0140-6736(19)30721-4. Epub 2019 Jun 27.
- Results publication: PubMed 19782998Wolf DG, Greenberg D, Shemer-Avni Y, Givon-Lavi N, Bar-Ziv J, Dagan R. Association of human metapneumovirus with radiologically diagnosed community-acquired alveolar pneumonia in young children. J Pediatr. 2010 Jan;156(1):115-20. doi: 10.1016/j.jpeds.2009.07.014.
- Results publication: PubMed 25714161Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.
- Results publication: PubMed 23089688Chiu NC, Lin HY, Hsu CH, Huang FY, Lee KS, Chi H. Epidemiological and microbiological characteristics of culture-proven acute otitis media in Taiwanese children. J Formos Med Assoc. 2012 Oct;111(10):536-41. doi: 10.1016/j.jfma.2011.07.015. Epub 2012 Mar 13.
- Individual participant dataSharing planned: No. We will record and analyze the individual participant data by our study team only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin Chi, Doctor principal investigator
Mackay Children's Hospital in Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Infection and Respiratory Syncytial Virus Infections, run by Mackay Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin Chi, Doctor (+886 975835388, chi4531@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household transmission of Streptococcus pneumoniae and Respiratory syncytial virus (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017519, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.