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.
Tahapan Penelitian : Recruit
Sponsor:
Partnerships for Enhanced Engagement in Research (PEER Health)
Mitra Pelaksana:
Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
No Registry
INA-PLE3XOP
Tanggal Input Registry : 08-11-2017
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 04-07-2017 |
| Outcome Primer | Develop the algorithm for the diagnosis of viral and bacterial pathogens in pediatric patients with pneumonia by identified pathogens from each clinical diagnosis |
| Outcome Skunder | - The etiology of pneumonia in children in Indonesia expressed in percentages of enrolled subjects - Report the outcomes of pediatric patients with pneumonia in Indonesia. - Sensitivities and specificities of selected RDTs, biomarkers of bacterial infections, standard of care procedures and the gold standars in determining the causes ofin differentiating virus and bacterial infections in pneumonia. - Sensitivities and specificities of combined tests in differentiating virus and bacterial infections in pneumonia. - Report the strains of circulating respiratory viruses and pathogens in children. |
| Descriptive Information | |
| Judul Penelitian Popular | 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. |
| Judul Penelitian Ilmiah | 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. |
| Jenis Penelitian | Observational |
| Intervensi | Not Applicable, this is observational study |
| Jumlah Subyek Penelitian | 275 |
| Recruitment Information | |
| 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) |
| Administrative Information | |
| Nomor Persetujuan Etik | Number: 567/UN2.F1/ETIK/2017 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | INA201 PEER-PePPes |
| Contact Person | Dr. Herman Kosasih, PhD |