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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 2018

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.

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: 

During the reporting period of October – December 2017, Tangerang Hospital and Kariadi Hospital were activated for the study. The screening and enrollment are ongoing at both sites. One additional site, Sardjito Hospital, is in preparation for study start-up. The local IRB full-board review result has been responded and the project team is awaiting feedback & approval for the ethical clearance. Once approved, the Clinical Research Site Specialist Team will start to prepare for Site Preparation Visit (SPV). A total of 19 subjects were enrolled: 14 subjects from Tangerang Hospital & 5 subjects from Kariadi Hospital. The recruitment target achieved 56% of the 2017 recruitment target (19 of 34 subject). The site monitoring visits have been performed at the active sites by the appointed Clinical Research Associate (CRA). The specimens and data were collected from two active sites. The purpose of adding Sardjito Hospital as a study site was to increase sample size, and remove the IV antibiotic administration in the exclusion criteria. The new OpenClinica screens went live on November 27 and other Data Management-related documents were shared with the study team during the reporting period.

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