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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Bacterial

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 Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia
      • Cipto Mangunkusumo Hospital - Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population target is the severe pneumonia patient in ED/ICU/HCU Cipto Mangunkusumo Hospital. The reachable population is moderate and severe CAP in ED/ICU/HCU, Cipto Mangunkusumo Hospital., Jakarta. The research subjects are the reachable population who meet the inclusion and exclusion criteria by consecutive sampling recruitment method

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the distribution of Streptococcus pneumoniae serotype and its prevalence	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.	Through study completion, an average of 2 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the antibiotics susceptibility of Streptococcus pneumoniae	To investigate the antibiotics susceptibility of Streptococcus pneumoniae in hospitalized adult patients with CAP	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Collaborators: Eijkman Institute for Molecular Biology
• Investigators: Principal Investigator: Gurmeet Singh, MD, PhD, Indonesian Society of Respirology

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal; Pneumonia, Bacterial
• Other Study ID Numbers: 61356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No