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.
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      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: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients with pneumonia whose ages range from 2 months to 5 years. This is a
        preliminary study to characterize the pathogens present in this cohort. The number of
        participants' that will be enrolled is based on the number of pneumonia cases in 5 years
        old children or less, which is approximately 100 patients per year in each hospital.
        Estimating that 50% of them failed to satisfy the inclusion and exclusion criteria, this
        study plan to enroll 50 participants per site per year, or a total of 275 participants.
      
Biospecimen description: 
      Subjects must be willing to allow storage of left over specimens (whole blood, serum, urine,
      NPS, sputum/induced sputum) and isolate from culture (if available)