Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05173727
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-12-10
Brief Title:
Prevalence and Serotype of Streptococcus Pneumoniae Hospitalized Adult With Community-Acquired Pneumonia
Sponsor:
Dr Cipto Mangunkusumo General Hospital
Organization:
Dr Cipto Mangunkusumo General Hospital
Study Overview
Official Title:
Prevalence and Serotype of Streptococcus Pneumoniae in Hospitalized Adult With Community-Acquired Pneumonia Isolated From Blood Nasopharyngeal Swab Urine andor Sputum
Status:
COMPLETED
Status Verified Date:
2023-11
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:
HACAP
Brief Summary:
Streptococcus Pneumoniae is one of the etiology in severe CAP and accounts for about 60-75 of cases and is likely to be the leading cause of unknown etiologic pneumonia In Indonesia studies regarding the prevalence of Streptococcus pneumoniae as the cause of CAP are still very rare Therefore there is still a need for further investigation in S pneumoniae prevalence among hospitalized CAP by utilizing different detection methods in Indonesia Antibiotics as a therapy of CAP also showed high levels of resistance meanwhile early detection of causative pathogen is potentially reducing the incidence of antibiotic resistance and usage of broad-spectrum antibiotics
Detailed Description:
Pneumonia is inflammation of the lungs by bacteria with symptoms of high fever accompanied by productive cough rapid breathing frequency of breath 50 timesminutes tightness and other symptoms headache restlessness and reduced appetite Pneumonia is a health problem in the world due to high morbidity and mortality Streptococcus pneumoniae is one of the etiology in severe community-acquired pneumonia CAP and accounts for about 60-75 of cases and is likely to be the leading cause of unknown etiologic pneumonia In Indonesia studies regarding the prevalence of Streptococcus pneumoniae as the cause of CAP are still very rare Previous study Amanda2020 found that Streptococcus pneumoniae prevalence isolated from CSF and blood in adult CAP patients is very low around 14 from 100 patients Therefore there is still a need for further investigation in S pneumoniae prevalence among hospitalized CAP by utilizing different detection methods in Indonesia
Diagnosis relies upon microbiological confirmation of Streptococcus pneumoniae in patients with clinical and radiological features of pneumonia Blood culture remains the gold standard for confirmation of Streptococcus pneumoniae and only occurs in 15-30 of cases Furthermore treatment with antibiotics before specimen sampling reduces the sensitivity in the majority of the cases Urine antigen detection is a non-invasive test to detect C polysaccharide antigen in urine has good sensitivity and very specific in the adult patient with Streptococcus pneumoniae infection A meta-analysis and systematic review in 2013 mentioned the sensitivity value of urine-based pneumococcal antigen reached 676 CI 95 and specificity 981 CI 95 In addition a study by Molinos et al 2015 found out that 21 of all caused CAP patients are positive with S pneumoniae detected by urine antigen test
Antibiotics as a therapy of CAP showed high levels of resistance Yu et al 2011 reported Streptococcus pneumoniae as the main cause of community-acquired pneumonia has been resistance to antibiotics of penicillin in vitro macrolides and quinolones Early detection of the causative pathogen can reduce the incidence of antibiotic resistance and the usage of broad-spectrum antibiotics
To investigators knowledge this study will be the first to assess and evaluate multiple methods for the detection of S pneumoniae by collecting and testing respiratory and non-respiratory samples from the hospitalized adult with CAP in Indonesia
Diagnosis relies upon microbiological confirmation of Streptococcus pneumoniae in patients with clinical and radiological features of pneumonia Blood culture remains the gold standard for confirmation of Streptococcus pneumoniae and only occurs in 15-30 of cases Furthermore treatment with antibiotics before specimen sampling reduces the sensitivity in the majority of the cases Urine antigen detection is a non-invasive test to detect C polysaccharide antigen in urine has good sensitivity and very specific in the adult patient with Streptococcus pneumoniae infection A meta-analysis and systematic review in 2013 mentioned the sensitivity value of urine-based pneumococcal antigen reached 676 CI 95 and specificity 981 CI 95 In addition a study by Molinos et al 2015 found out that 21 of all caused CAP patients are positive with S pneumoniae detected by urine antigen test
Antibiotics as a therapy of CAP showed high levels of resistance Yu et al 2011 reported Streptococcus pneumoniae as the main cause of community-acquired pneumonia has been resistance to antibiotics of penicillin in vitro macrolides and quinolones Early detection of the causative pathogen can reduce the incidence of antibiotic resistance and the usage of broad-spectrum antibiotics
To investigators knowledge this study will be the first to assess and evaluate multiple methods for the detection of S pneumoniae by collecting and testing respiratory and non-respiratory samples from the hospitalized adult with CAP in Indonesia
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