Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients

Completed

Conditions: Pneumonia

Registration Number: NCT03366454

Lead Sponsor: INA-RESPOND Secretariat

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 188

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens	Total length of time the subject will be in the study is one month after enrollment.	The area under the receiver operating curve (AUROC) for WBC and ANC count at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens	Total length of time the subject will be in the study is one month after enrollment.	The area under the receiver operating curve (AUROC) for CRP at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens	Total length of time the subject will be in the study is one month after enrollment.	The area under the receiver operating curve (AUROC) for PCT at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens	Total length of time the subject will be in the study is one month after enrollment.	The area under the receiver operating curve (AUROC) for NLR at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.

Secondary Outcome Measures

Name	Time	Method
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.	Total length of time the subject will be in the study is one month after enrollment.	Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays.
The Clinical Outcome in Pneumonia Pediatric Subjects	Total length of time the subject will be in the study is one month after enrollment.	Data and specimens were collected at enrollment and 14 days after enrollment. A telephone interview was done on day 30 to assess the clinical outcome. The outcome report was expressed in percentages of enrolled subjects and the proportions of subjects within each category defined by cured and death.
The Percentage of Sign and Symptom of SoC Procedure	Total length of time the subject will be in the study is one month after enrollment.	The percentage of sign and symptom of SoC procedure of pneumonia pediatric subjects expressed in percentages of identified pathogens. The proportion of subjects within each category is defined by bacterial or mixed infections and viral infections. We analyzed only 155 subjects with confirmed etiology for this secondary outcome.
Performance of Combined Factors in Differentiating Viral and Bacterial Infections	Total length of time the subject will be in the study is one month after enrollment.	We explored the combination of significant factors/variables in the multivariate analysis for their overall sensitivity and specificity for discriminating bacterial/mixed and viral infection. The combination variables were CRP ≥5.70 mg/L + fever, CRP ≥5.70 mg/L + dry season, and CRP ≥5.70 mg/L + fever + dry season. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects	Total length of time the subject will be in the study is one month after enrollment.	Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays. We analyzed only 155 subjects with confirmed etiology for this secondary outcome.

Trial Locations

Locations (4): University of Diponegoro/ Dr. Kariadi Hospital
🇮🇩
Semarang, Central Java, Indonesia
University of Gadjah Mada/ Dr. Sardjito Hospital
🇮🇩
Yogyakarta, DIY Yogyakarta, Indonesia
RSU Kabupaten Tangerang
🇮🇩
Tangerang, West Java, Indonesia
An-Nisa Hospital
🇮🇩
Tangerang, West Java, Indonesia
University of Diponegoro/ Dr. Kariadi Hospital
🇮🇩Semarang, Central Java, Indonesia