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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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)
结局指标
主要结局
White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
时间窗: 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.
Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
时间窗: 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.
CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
INA-RESPOND Secretariat
dr. Herman Kosasih, PhD
Ina-Respond