Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279624
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-05
Brief Title:
Effectiveness of the PCV13 in Older Thai Adults
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Effectiveness of the 13-Valent Pneumococcal Conjugated Vaccine Against Community-Acquired Pneumonia in Older Thai Adults A Matched Case-Control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the matched 12 case-control study prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia CAP accordingly from November 2023 through October 2024 The investigators define a CASE as a person aged 60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge While a CONTROL is defined as a person aged 60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge
The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine PCV13 in pneumococcal CAP in Thai adults aged 60 years with or without any medical conditions
The main questions it aims to answer is
What are the effectiveness of PCV13 for preventing all typed vaccine typed or non-vaccine typed of pneumococcal CAP among Thai older adults
The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023 The investigators define case and control the same as prospective method but all data were retrieved from archive database
-The investigators select a 12 matched control with criteria as follows 10-year-interval of age ward the same patient care such as out or in-patient or admitted in the same level ward
Participants will be
collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition
explored their vaccine status by either vaccine book checking or hospital database
Researcher will compare the effectiveness of PCV13 to prevent all typed vaccine typed and non-vaccine typed pneumococcal pneumonia
The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine PCV13 in pneumococcal CAP in Thai adults aged 60 years with or without any medical conditions
The main questions it aims to answer is
What are the effectiveness of PCV13 for preventing all typed vaccine typed or non-vaccine typed of pneumococcal CAP among Thai older adults
The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023 The investigators define case and control the same as prospective method but all data were retrieved from archive database
-The investigators select a 12 matched control with criteria as follows 10-year-interval of age ward the same patient care such as out or in-patient or admitted in the same level ward
Participants will be
collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition
explored their vaccine status by either vaccine book checking or hospital database
Researcher will compare the effectiveness of PCV13 to prevent all typed vaccine typed and non-vaccine typed pneumococcal pneumonia
Detailed Description:
The investigators select a 12 matched control with criteria as follows 10-year-interval of age ward the same patient care such as out or in-patient or admitted in the same level ward
Patient data will be collected through review of medical records and interview of the patients or their relatives for visits to the doctors using standard Case Record Form CRF by trained research assistance
Definition of CAP is defined according to clinical evidence and radiological evidence17 The clinical evidence consists of 2 of the following fever hypothermia chills or rigors pleuritic chest pain cough sputum production dyspnea tachypnea malaise or abnormal auscultatory findings suggestive of pneumonia while the radiological evidence includes a chest radiograph andor a computed tomographic image with an infiltrate consistent with pneumonia as determined by the treating healthcare provider or radiologist at the time of presentation The investigators consider PCV13 status when the vaccine has been given 14 days before onset of CAP for cases or 14 days before the date of admission for control The PCV13 status is ascertained by staff blinded to whether the patients are case or control Status will be confirmed by hospital record or vaccination card If history of vaccination is verbal confirmation by patient or their relatives then the investigators plan to figure vaccine status out in all hospitals that individuals has visited before admission
Patient data will be collected through review of medical records and interview of the patients or their relatives for visits to the doctors using standard Case Record Form CRF by trained research assistance
Definition of CAP is defined according to clinical evidence and radiological evidence17 The clinical evidence consists of 2 of the following fever hypothermia chills or rigors pleuritic chest pain cough sputum production dyspnea tachypnea malaise or abnormal auscultatory findings suggestive of pneumonia while the radiological evidence includes a chest radiograph andor a computed tomographic image with an infiltrate consistent with pneumonia as determined by the treating healthcare provider or radiologist at the time of presentation The investigators consider PCV13 status when the vaccine has been given 14 days before onset of CAP for cases or 14 days before the date of admission for control The PCV13 status is ascertained by staff blinded to whether the patients are case or control Status will be confirmed by hospital record or vaccination card If history of vaccination is verbal confirmation by patient or their relatives then the investigators plan to figure vaccine status out in all hospitals that individuals has visited before admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None