Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.

Study Overview
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Brief Summary
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Participants who meet the inclusion and exclusion criteria will be enrolled and then having a daily follow up for maximum of 13 days' hospitalization. Next follow up will be taken time at day 14th after hospitalization date, either on ward or policlinic. The participations will be ended by day 30th after hospitalization date when the called follow up is done by investigator.

Detailed Description
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This study will collect demographic data, medical history, clinical data, treatment, and risk factors of pneumonia. The study also record the supporting examination results include but not limited to Complete Blood Count (CBC) results, blood gas analyses result, CRP, PCT, culture result, rapid test for influenza, Respiratory Syncytial Virus (RSV), legionella, and chest X-ray. In order to produce a robust data, this study will conduct the serological and molecular tests at the reference laboratory. Whole blood, serum, urine, Nasal Pharyngeal Swab (NPS), sputum/induced sputum, and other respiratory specimens (if available) will be collected for storage and testing at enrollment. Plasma from 48-72 hours after hospitalization and left-over respiratory specimens on day 2 and 3 of hospitalization will also be collected to be stored. For additional, at day 14th after hospitalization serum will be processed from 4 mL of blood for archiving and testing at the reference laboratory. This study will be conducted at following INA-RESPOND sites: RSU Kabupaten Tangerang, Tangerang RSUP Dr. Kariadi, Semarang RSUP Dr. Sardjito, Yogyakarta RSU Kabupaten Tangerang located in Banten province is type B or district referral hospital. While RSUP Dr Kariadi in Semarang and RSUP Dr Sardjito in Yogyakarta are type A hospital which is a level of province referral. Maximum duration for participants' accrual will be 2 years since the first participant enrolled. However, the study laboratory testing may take up to 6 months to be completed.

Official Title
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Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.

Conditions
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Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric inpatients whose ages range from 2 months to 5 years Meet the case definition for pneumonia which is cough or fever with at least one other following symptoms: Shortness of breath Tachypnea Grunting Crackles/rhonchi Decreased vesicular breath sound Bronchial breath sound Chest x-ray consistent with pneumonia Comply with all study procedures including to store required specimens for diagnostic testing and archiving. Exclusion Criteria: Being Hospitalized for more than 24 hours at enrollment Having a cancer or history of cancer Having a history of long term exposed of steroid (at the minimum of 2 months) Having any condition that might interfere with study procedure and compliance (based on clinicians' judgement)

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop an algorithm for the diagnosis of viral and bacterial pathogens in pediatric patients with pneumonia. | Develop the algorithm for the diagnosis of viral and bacterial pathogens from 275 enrolled paediatric patients with pneumonia by identified pathogens from each clinical diagnosis | 26 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the etiologies of pneumonia in children in Indonesia, which are currently unavailable. | The etiology (bacteria, viruses, parasites, fungi and others) of pneumonia in children expressed in percentages of enrolled subjects. | 26 Months | 
| To document outcomes in pediatric patients with pneumonia in Indonesia. | Report the outcomes of paediatric patients with pneumonia in Indonesia expressed in percentages of enrolled subjects and the proportions of subjects within each category defined by cured, improved, worsened and death. | 26 Months | 
| To evaluate the performance of each rapid point of care test and standard of care procedures (Chest X-ray) compared to the gold standard molecular assays in differentiating virus and bacterial infections. | Measuring sensitivity and specificity of selected RTDs, biomarkers of bacterial infections, standard of care procedures against result in the gold standard along with 97.5% confidence intervals. | 26 Months | 
| To analyze the performance of combined tests in differentiating virus and bacterial infections. Sensitivities and specificities of combined tests in differentiating virus and bacterial infections in pneumonia. | Measuring sensitivity and specificity of combined tests (RTDs and biomarker of bacterial infections versus standard of care procedures; standard of care procedures versus the gold standard) in differentiating virus and bacterial infections along with 97.5% confidence intervals. | 26 Months | 
| To provide information regarding updated strains of circulating respiratory viruses and pathogens in children. | Report the strains of circulating respiratory viruses and pathogens of pediatric patients with pneumonia in Indonesia expressed in percentages of the identified strains from the enrolled subjects. | [Time Frame: 26 Months] |