Trial Outcomes & Findings for Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients (NCT NCT03366454)
NCT ID: NCT03366454
Last Updated: 2025-06-04
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
188 participants
Primary outcome timeframe
Total length of time the subject will be in the study is one month after enrollment.
Results posted on
2025-06-04
Participant Flow
Recruitment period was done from July 2017 to September 2019
From total target 275 subjects only achieved 188 subjects enrolled
Participant milestones
| Measure |
Hospitalized Pediatric Participants With Pneumonia
Hospitalized pediatric patients with pneumonia at acute episode.
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Hospitalized Pediatric Participants With Pneumonia
n=188 Participants
Hospitalized pediatric patients with pneumonia at acute episode
|
|---|---|
|
Age, Categorical
<=18 years
|
188 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
188 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
|
12.2 10^3 cells/microliter
|
6.15 10^3 cells/microliter
|
—
|
—
|
PRIMARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
|
1.34 ratio
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
|
5.70 mg/dL
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
|
0.141 ng/mL
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All participants who have specimens to be tested
Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=188 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Bacterial
|
48 Participants
|
—
|
—
|
—
|
|
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Viruses
|
31 Participants
|
—
|
—
|
—
|
|
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Mixed pathogens
|
76 Participants
|
—
|
—
|
—
|
|
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Unidentified pathogens
|
33 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects enrolled with clinical data.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=48 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=31 Participants
The ANC count data 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.
|
Mixed Pathogens
n=76 Participants
Identified etiology based on laboratory testing
|
Unidentified Pathogens
n=33 Participants
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
The Clinical Outcome in Pneumonia Pediatric Subjects
Cured
|
41 Participants
|
29 Participants
|
71 Participants
|
28 Participants
|
|
The Clinical Outcome in Pneumonia Pediatric Subjects
Death
|
7 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=124 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=31 Participants
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
The Percentage of Sign and Symptom of SoC Procedure
Skin rash
|
6 Participants
|
2 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Cough
|
116 Participants
|
27 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Shortness of breath
|
116 Participants
|
28 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Fever
|
105 Participants
|
22 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Decreased consciousness
|
6 Participants
|
0 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Inability to drink
|
10 Participants
|
2 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Diarrhea
|
30 Participants
|
1 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Vomiting
|
9 Participants
|
2 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Seizure
|
5 Participants
|
1 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Tachypnea
|
54 Participants
|
13 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Intercostal retraction
|
112 Participants
|
27 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Ronchi
|
115 Participants
|
25 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Wheezing
|
20 Participants
|
2 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Nasal Flaring
|
49 Participants
|
11 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Chest indrawing
|
85 Participants
|
18 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Head bobbing
|
7 Participants
|
2 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
SpO2 <90%
|
29 Participants
|
6 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Severe/ very severe pneumonia (WHO classification 2014)
|
55 Participants
|
16 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Chest X-ray Pleural effusion
|
3 Participants
|
1 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Chest X-ray- Interstitial infiltrate
|
93 Participants
|
19 Participants
|
—
|
—
|
|
The Percentage of Sign and Symptom of SoC Procedure
Chest X-ray-Alveolar infiltrate
|
86 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The ANC count data 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.
|
Mixed Pathogens
n=155 Participants
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
Sensitivity
|
62.28 percentage of participants
|
40.35 percentage of participants
|
35.09 percentage of participants
|
—
|
|
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
Specificity
|
65.52 percentage of participants
|
82.76 percentage of participants
|
86.21 percentage of participants
|
—
|
|
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
PPV
|
87.65 percentage of participants
|
90.19 percentage of participants
|
90.91 percentage of participants
|
—
|
|
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
NPV
|
30.64 percentage of participants
|
26.09 percentage of participants
|
25.25 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Total length of time the subject will be in the study is one month after enrollment.Population: All subjects with confirmed etiology.
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.
Outcome measures
| Measure |
White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
n=155 Participants
The WBC count data 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.
|
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The ANC count data 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.
|
Mixed Pathogens
Identified etiology based on laboratory testing
|
Unidentified Pathogens
Identified etiology based on laboratory testing
|
|---|---|---|---|---|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Streptococcus pneumoniae
|
29 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Staphylococcus aureus
|
20 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Streptococcus mitis
|
4 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Streptococcus pyogenes
|
1 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Moraxella catarrhalis
|
2 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Haemophilus influenzae non type B
|
73 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Klebsiella pneumoniae
|
43 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Bordetella pertussis
|
7 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Escherichia coli
|
5 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Pseudomonas aeruginosa
|
4 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Acinetobacter baumannii
|
3 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Haemophilus influenzae type B
|
2 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Neisseria meningitidis
|
1 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Chlamydia pneumoniae
|
5 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Mycoplasma pneumonia
|
5 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Legionella pneumophila
|
1 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
RSV A
|
15 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
RSV B
|
36 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Influenza
|
25 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Influenza A (H1N1)
|
7 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Influenza A (H3N2)
|
3 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Influenza B
|
14 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
PIV 1
|
5 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
PIV 3
|
11 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
PIV 4
|
1 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
hMPV
|
11 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Rhinovirus
|
10 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Enterovirus
|
5 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Bocavirus
|
3 participants
|
—
|
—
|
—
|
|
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
hCoV-NL63
|
2 participants
|
—
|
—
|
—
|
Adverse Events
Obervational
Serious events: 0 serious events
Other events: 1 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Obervational
n=188 participants at risk
Hospitalized pediatric participants with pneumonia
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.53%
1/188 • Number of events 1 • 2 years, 2 months
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related specimen collection that is possibly, probably, or definitely related to the blood draw or induced sputum. Any event outside of this 48 hour window period will not be considered an AE for this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place