Pneumonia
Conditions
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.
Interventions
None listed
Sponsors
United States Agency for International Development (USAID)
Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
INA-RESPOND Secretariat
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Indonesia
Participant flow
Recruitment details
Recruitment period was done from July 2017 to September 2019
Pre-assignment details
From total target 275 subjects only achieved 188 subjects enrolled
Participants by arm
| Arm | Count |
|---|---|
| Hospitalized Pediatric Participants With Pneumonia Hospitalized pediatric patients with pneumonia at acute episode | 188 |
| Total | 188 |
Baseline characteristics
| Characteristic | Hospitalized Pediatric Participants With Pneumonia |
|---|---|
| Age, Categorical <=18 years | 188 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 188 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 188 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Indonesia | 188 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 188 |
| other Total, other adverse events | 1 / 188 |
| serious Total, serious adverse events | 0 / 188 |
Outcome results
Primary
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens | 5.70 mg/dL |
Comparison: ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)p-value: 0.001895% CI: [0.5962, 0.7807]ROC Curve Analysis
Primary
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens | 1.34 ratio |
Comparison: ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).p-value: 0.023395% CI: [0.5335, 0.7544]ROC Curve Analysis
Primary
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens | 0.141 ng/mL |
Comparison: ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).p-value: 0.000795% CI: [0.6111, 0.8015]ROC Curve Analysis
Primary
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | 12.2 10^3 cells/microliter |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | 6.15 10^3 cells/microliter |
Comparison: ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)p-value: 0.004895% CI: [0.5649, 0.7735]ROC Curve Analysis
Comparison: ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).p-value: 0.002995% CI: [0.587, 0.7914]ROC Curve Analysis
Secondary
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Streptococcus pneumoniae | 29 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Staphylococcus aureus | 20 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Streptococcus pyogenes | 1 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Moraxella catarrhalis | 2 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Haemophilus influenzae non type B | 73 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Klebsiella pneumoniae | 43 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Bordetella pertussis | 7 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Legionella pneumophila | 1 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | RSV A | 15 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | RSV B | 36 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Influenza B | 14 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | PIV 1 | 5 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | PIV 3 | 11 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Enterovirus | 5 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Bocavirus | 3 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Streptococcus mitis | 4 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Escherichia coli | 5 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Pseudomonas aeruginosa | 4 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Acinetobacter baumannii | 3 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Haemophilus influenzae type B | 2 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Neisseria meningitidis | 1 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Chlamydia pneumoniae | 5 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Mycoplasma pneumonia | 5 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Influenza | 25 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Influenza A (H1N1) | 7 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Influenza A (H3N2) | 3 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | PIV 4 | 1 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | hMPV | 11 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | Rhinovirus | 10 participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects | hCoV-NL63 | 2 participants |
Secondary
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Specificity | 65.52 percentage of participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | NPV | 30.64 percentage of participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Sensitivity | 62.28 percentage of participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | PPV | 87.65 percentage of participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Specificity | 82.76 percentage of participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | PPV | 90.19 percentage of participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | NPV | 26.09 percentage of participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Sensitivity | 40.35 percentage of participants |
| Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | NPV | 25.25 percentage of participants |
| Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Specificity | 86.21 percentage of participants |
| Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | PPV | 90.91 percentage of participants |
| Mixed Pathogens | Performance of Combined Factors in Differentiating Viral and Bacterial Infections | Sensitivity | 35.09 percentage of participants |
Secondary
The Clinical Outcome in Pneumonia Pediatric Subjects
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects enrolled with clinical data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Cured | 41 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Death | 7 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Death | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Cured | 29 Participants |
| Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Cured | 71 Participants |
| Mixed Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Death | 5 Participants |
| Unidentified Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Cured | 28 Participants |
| Unidentified Pathogens | The Clinical Outcome in Pneumonia Pediatric Subjects | Death | 5 Participants |
Secondary
The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects. | Bacterial | 48 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects. | Viruses | 31 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects. | Mixed pathogens | 76 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects. | Unidentified pathogens | 33 Participants |
Secondary
The Percentage of Sign and Symptom of SoC Procedure
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.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Population: All subjects with confirmed etiology.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Tachypnea | 54 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Diarrhea | 30 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Vomiting | 9 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Intercostal retraction | 112 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Cough | 116 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Ronchi | 115 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray Pleural effusion | 3 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Wheezing | 20 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Shortness of breath | 116 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Nasal Flaring | 49 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Seizure | 5 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest indrawing | 85 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Fever | 105 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Head bobbing | 7 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray- Interstitial infiltrate | 93 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Skin rash | 6 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Decreased consciousness | 6 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | SpO2 <90% | 29 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray-Alveolar infiltrate | 86 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Severe/ very severe pneumonia (WHO classification 2014) | 55 Participants |
| White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Inability to drink | 10 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray- Interstitial infiltrate | 19 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Vomiting | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Seizure | 1 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Tachypnea | 13 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Severe/ very severe pneumonia (WHO classification 2014) | 16 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray Pleural effusion | 1 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest X-ray-Alveolar infiltrate | 19 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Cough | 27 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Shortness of breath | 28 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Fever | 22 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Decreased consciousness | 0 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Inability to drink | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Intercostal retraction | 27 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Ronchi | 25 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Wheezing | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Nasal Flaring | 11 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Chest indrawing | 18 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Head bobbing | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Skin rash | 2 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | SpO2 <90% | 6 Participants |
| Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens | The Percentage of Sign and Symptom of SoC Procedure | Diarrhea | 1 Participants |