NCT Number: NCT03366454
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.
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Notify Me2 month–5 year
All sexes
Observational
University of Diponegoro/ Dr. Kariadi Hospital, Semarang, Central Java, Indonesia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
INA-RESPOND Secretariat
Other
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.
Acronym: PEER-PePPes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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