N/A
N=188
Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients
Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT03366454 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens — 12.2; 6.15 10^3 cells/microliter — p=0.0048
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- INA-RESPOND Secretariat
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens |
12.2; 6.15 | 0.0048 sig |
| PRIMARY Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens |
1.34 | 0.0233 sig |
| PRIMARY CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens |
5.70 | 0.0018 sig |
| PRIMARY Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens |
0.141 | 0.0007 sig |
| SECONDARY The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects. |
48; 31; 76; 33 | — |
| SECONDARY The Clinical Outcome in Pneumonia Pediatric Subjects |
41; 29; 71; 28; 7; 2 | — |
| SECONDARY The Percentage of Sign and Symptom of SoC Procedure |
116; 27; 116; 28; 105; 22 | — |
| SECONDARY Performance of Combined Factors in Differentiating Viral and Bacterial Infections |
62.28; 40.35; 35.09; 65.52; 82.76; 86.21 | — |
| SECONDARY Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects |
29; 20; 4; 1; 2; 73 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03366454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.