Clinical trial NCT03366454: Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: Ina-Respond
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
First posted: 2017-12-08
Enrollment: 188
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
Secondary outcomes:
measure: The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: The Clinical Outcome in Pneumonia Pediatric Subjects
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: The Percentage of Sign and Symptom of SoC Procedure
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: Performance of Combined Factors in Differentiating Viral and Bacterial Infections
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
measure: Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
timeFrame: Total length of time the subject will be in the study is one month after enrollment.
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: University of Diponegoro/ Dr. Kariadi Hospital
state: Central Java
city: Yogyakarta
country: Indonesia
facility: University of Gadjah Mada/ Dr. Sardjito Hospital
state: DIY Yogyakarta
city: Tangerang
country: Indonesia
facility: RSU Kabupaten Tangerang
state: West Java
city: Tangerang
country: Indonesia
facility: An-Nisa Hospital
state: West Java
Study officials:
affiliation: Ina-Respond
name: Dr. Herman Kosasih, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lokida D, Farida H, Triasih R, Mardian Y, Kosasih H, Naysilla AM, Budiman A, Hayuningsih C, Anam MS, Wastoro D, Mujahidah M, Dipayana S, Setyati A, Aman AT, Lukman N, Karyana M, Kline A, Neal A, Lau CY, Lane C. Epidemiology of community-acquired pneumonia among hospitalised children in Indonesia: a multicentre, prospective study. BMJ Open. 2022 Jun 21;12(6):e057957. doi: 10.1136/bmjopen-2021-057957.