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Completed

NCT Number: NCT05173727

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Hospital - Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Determine the distribution of Streptococcus pneumoniae serotype and its prevalence

    Time frame: 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 outcomes

  1. To investigate the antibiotics susceptibility of Streptococcus pneumoniae

    Time frame: Through study completion, an average of 2 year

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

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Collaborators

  • Eijkman Institute for Molecular Biology

Registry information

Official study title

Prevalence and Serotype of Streptococcus Pneumoniae in Hospitalized Adult With Community-Acquired Pneumonia: Isolated From Blood, Nasopharyngeal Swab, Urine, and/or Sputum

Acronym: HACAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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