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Cycle 5 (2016 Deadline)

Implementing a combination of rapid diagnostic tests, biomarkers and standard of care procedures for the diagnosis of pneumonia in pediatric patients to improve clinical management in Indonesia

PI: Herman Kosasih (, INA RESPOND
U.S. Partner: Clifford Lane, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Project dates: December 2016 - November 2019

Project Overview:

Pneumonia is the leading cause of death in children below five years of age. While advances have been made in the management of childhood pneumonia, gaps remain that may hinder efforts to reduce morbidity and mortality. These gaps include the absence of a universally accepted diagnostic gold standard for childhood pneumonia, especially one that can also differentiate between bacterial and non-bacterial pneumonia. This study will evaluate the use of an algorithm utilizing several rapid diagnostic tests (RDT), biomarkers, and standard of care (SOC) procedures in differentiating these different pathogens in pediatric patients admitted to Tangerang and Kariadi hospitals in Indonesia. Secondary objectives of the study include (1) identifying the etiologies of pneumonia in children in Indonesia; (2) documenting outcomes; (3) evaluating the use of each RDT (influenza, RSV, Pneumococcus), biomarkers (CRP, PCT), and SOC in distinguishing viral and bacterial pathogens; and (4) providing updated strains of circulating viruses, bacteria, and antibiotic resistance.

5-408 Team Meeting
The results of this study will impact case management in children with pneumonia, from accurate diagnosis to appropriate treatment and development of prevention strategies. Subsequently, they should contribute significantly to the reduction of childhood morbidity and mortality in Indonesia. The proposed clinical pathway can inform management policies at the hospitals and highlight potential etiologies and diagnostics that should be considered by clinicians, microbiologists, and clinical pathologists. This clinical pathway may also change the policies of the national insurance company by informing decisions on the diagnostic testing that is covered under the program currently and improving the cost-benefit ratio. Improved diagnostics and treatments can enable earlier commencement of appropriate treatment and decreased hospitalization time. The identification of influenza or other viruses as the causes of pneumonia can help to change the current perceptions of clinicians and health policy makers regarding the ability of these viruses to cause severe illness and improve provision of antivirals. As the awareness will be enhanced and new policies may be applied, the private sector (e.g., pharmaceutical companies and diagnostic test manufacturers) may be motivated to improve the performance of their products with regard to efficacy, sensitivity, and specificity. The team's research may also have an impact on enhancing surveillance for pathogens, especially influenza H5N1, that may cause a pandemic threat. Improved information regarding the pathogens causing pneumonia will help to identify and highlight research priorities in pediatric pneumonia and also enable health programs to develop improved control and prevention measures at the community level.

Summary of Recent Activities: 

As of the end of June 2019, 466 patients were screened resulting in 33.3% (155) subjects being enrolled (65 subjects from Tangerang hospital, 39 subjects from Kariadi hospital, 39 subjects from Sardjito hospital, and 12 subjects from An Nisa hospital). The most common screen failure reasons were: subjects were hospitalized more than 24 hours at enrollment, subjects had a condition that might interfere with study procedure and compliance (based on clinicians’ judgment), and subjects refuse to join the study. Tugurejo Hospital and Bhakti Wira Tamtama Hospital were activated as satellite sites under Kariadi Hospital during this reporting period to increase enrollment of subjects. The major challenge that the project team faces is determining the probable etiology. Distinguishing colonization from infection is also a major challenge when these organisms are detected in respiratory specimens. The detection of multiple potential pathogens in a single patient can also present a problem with assigning causality. Beside literature reviews, the PIs are approaching to collaborate in testing the specimen using Biofire Filmarray® systems from Biomerieux. The Biofire filmarray is a certified multiplex PCR system that enables simultaneous testing for bacteria, viruses, yeast, parasites, and antimicrobial resistant genes. We expect to analyze the testing agreement between RT-PCR assay and Biofire Filmarray.

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