HACAP: Prevalence and Serotype of Streptococcus Pneumoniae Hospitalized Adult With Community-Acquired Pneumonia

Sponsor
Departement of Internal Medicine Division of Respirology and Critical Care Internal Medicine Departm (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05173727
Collaborator
Eijkman Institute for Molecular Biology (Other)
350
21.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 times/minutes), 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 (Amanda,2020) 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 67.6% (CI 95%) and specificity 98.1% (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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence and Serotype of Streptococcus Pneumoniae in Hospitalized Adult With Community-Acquired Pneumonia: Isolated From Blood, Nasopharyngeal Swab, Urine, and/or Sputum
    Anticipated Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Determine the distribution of Streptococcus pneumoniae serotype and its prevalence [Through study completion, an average of 2 year.]

      Determine the distribution of Streptococcus pneumoniae serotype and its prevalence isolated from hospitalized adult patients with CAP in Cipto Mangunkusumo Hospital, Jakarta, Indonesia utilizing different methods.

    Secondary Outcome Measures

    1. To investigate the antibiotics susceptibility of Streptococcus pneumoniae [Through study completion, an average of 2 year]

      To investigate the antibiotics susceptibility of Streptococcus pneumoniae in hospitalized adult patients with CAP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hospitalized adult ≥ 18 years old

    • Moderate to severe CAP (CURB-65 score > 2 dan ATS/IDSA 2019)

    Exclusion Criteria:
    • Have been taking antibiotic more than 24 hours before enrollment.

    • Diagnose with non-infectious ARDS disease (such as aspiration pneumonia or cardiogenic pulmonary edema).

    • Diagnose with tuberculosis based on clinical or radiological findings.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Departement of Internal Medicine Division of Respirology and Critical Care Internal Medicine Departm
    • Eijkman Institute for Molecular Biology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gurmeet Singh, MD, Head Division Respirology and Critical Illness, Internal Medicine Department, Principal Investigator, Respirology and Critical Illness Consultant, Dr Cipto Mangunkusumo General Hospital
    ClinicalTrials.gov Identifier:
    NCT05173727
    Other Study ID Numbers:
    • 61356
    First Posted:
    Dec 30, 2021
    Last Update Posted:
    Dec 30, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 30, 2021