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

NCT03366454 | Completed Results

• 2 other identifiers: INA201U1111-1263-2368
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 4

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (4)

• White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens

  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.

  Total length of time the subject will be in the study is one month after enrollment.

• Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

  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.

  Total length of time the subject will be in the study is one month after enrollment.

• CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

  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.

  Total length of time the subject will be in the study is one month after enrollment.

• Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

  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.

  Total length of time the subject will be in the study is one month after enrollment.

Secondary Outcomes (5)

• 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.

• The Clinical Outcome in Pneumonia Pediatric Subjects

  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

  Total length of time the subject will be in the study is one month after enrollment.

• 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.

• 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.

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• INA-RESPOND Secretariat: lead
• United States Agency for International Development (USAID): collaborator
• Indonesia Research Partnership on Infectious Disease (INA-RESPOND): collaborator

Study Sites (4)

University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central Java, 50244, Indonesia

Location

University of Gadjah Mada/ Dr. Sardjito Hospital

Yogyakarta, DIY Yogyakarta, 55284, Indonesia

Location

RSU Kabupaten Tangerang

Tangerang, West Java, 15111, Indonesia

Location

An-Nisa Hospital

Tangerang, West Java, 15132, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 35728910 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Publication Division
• Organization: INA-RESPOND

inapublikasi@ina-respond.net

+62214208693

Study Officials

• Dr. Herman Kosasih, PhD

  Ina-Respond

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dr. Herman Kosasih, PhD

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 8, 2017
• Study Start: July 4, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)