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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-2368 | Other Identifier | WHO UTN Number |
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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| Indonesia Research Partnership on Infectious Disease (INA-RESPOND) | UNKNOWN |
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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Total length of time the subject will be in the study is one month after enrollment. |
| The Clinical Outcome in Pneumonia Pediatric Subjects |
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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:
Comply with all study procedures including to store required specimens for diagnostic testing and archiving.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Herman Kosasih, PhD | Ina-Respond | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Diponegoro/ Dr. Kariadi Hospital | Semarang | Central Java | 50244 | Indonesia | ||
| University of Gadjah Mada/ Dr. Sardjito Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35728910 | Derived | 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. |
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From total target 275 subjects only achieved 188 subjects enrolled
Recruitment period was done from July 2017 to September 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospitalized Pediatric Participants With Pneumonia | Hospitalized pediatric patients with pneumonia at acute episode. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospitalized Pediatric Participants With Pneumonia | Hospitalized pediatric patients with pneumonia at acute episode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects with confirmed etiology. | Posted | Number | 10^3 cells/microliter | Total length of time the subject will be in the study is one month after enrollment. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obervational | Hospitalized pediatric participants with pneumonia | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hematoma at the site where blood is drawn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Publication Division | INA-RESPOND | +62214208693 | inapublikasi@ina-respond.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 13, 2019 | Nov 19, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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)
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. |
| 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 | 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. | 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 | 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. | 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 | 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. | Total length of time the subject will be in the study is one month after enrollment. |
| Yogyakarta |
| DIY Yogyakarta |
| 55284 |
| Indonesia |
| RSU Kabupaten Tangerang | Tangerang | West Java | 15111 | Indonesia |
| An-Nisa Hospital | Tangerang | West Java | 15132 | Indonesia |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Number | ratio | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Number | mg/dL | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Number | ng/mL | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
|
| 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. | All participants who have specimens to be tested | Posted | Count of Participants | Participants | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
| 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. | All subjects enrolled with clinical data. | Posted | Count of Participants | Participants | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Count of Participants | Participants | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Number | percentage of participants | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
| 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. | All subjects with confirmed etiology. | Posted | Number | participants | Total length of time the subject will be in the study is one month after enrollment. |
|
|
|
| 188 |
| 0 |
| 188 |
| 1 |
| 188 |
|
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| Title | Measurements |
|---|---|
|
| Unidentified pathogens |
|
| Death |
|
| Fever |
|
| Decreased consciousness |
|
| Inability to drink |
|
| Diarrhea |
|
| Vomiting |
|
| Seizure |
|
| Tachypnea |
|
| Intercostal retraction |
|
| Ronchi |
|
| Wheezing |
|
| Nasal Flaring |
|
| Chest indrawing |
|
| Head bobbing |
|
| Skin rash |
|
| SpO2 <90% |
|
| Severe/ very severe pneumonia (WHO classification 2014) |
|
| Chest X-ray Pleural effusion |
|
| Chest X-ray- Interstitial infiltrate |
|
| Chest X-ray-Alveolar infiltrate |
|
| Title | Measurements |
|---|---|
|
| PPV |
|
| NPV |
|
| Title | Measurements |
|---|---|
|
| Streptococcus pyogenes |
|
| Moraxella catarrhalis |
|
| Haemophilus influenzae non type B |
|
| Klebsiella pneumoniae |
|
| Bordetella pertussis |
|
| Escherichia coli |
|
| Pseudomonas aeruginosa |
|
| Acinetobacter baumannii |
|
| Haemophilus influenzae type B |
|
| Neisseria meningitidis |
|
| Chlamydia pneumoniae |
|
| Mycoplasma pneumonia |
|
| Legionella pneumophila |
|
| RSV A |
|
| RSV B |
|
| Influenza |
|
| Influenza A (H1N1) |
|
| Influenza A (H3N2) |
|
| Influenza B |
|
| PIV 1 |
|
| PIV 3 |
|
| PIV 4 |
|
| hMPV |
|
| Rhinovirus |
|
| Enterovirus |
|
| Bocavirus |
|
| hCoV-NL63 |
|