INA101: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE)
Tahapan Penelitian : Recruit
Sponsor:
National Institute of Health Research and Development (NIHRD), Indonesia and The National Institute of Allergy and Infectious Diseases, United States
Mitra Pelaksana:
INA-RESPOND Network
No Registry
INA-9WS4RE6
Tanggal Input Registry : 28-03-2016
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-06-2013 |
| Outcome Primer | Primary Objective: The etiologies (bacteria, viruses, parasites, fungi and others) of fever illness expressed in percentages of enrolled subjects. |
| Outcome Skunder | Secondary Objectives: - Signs, symptoms and clinical laboratory data from each confirmed diagnosis will be calculated in percentages. An algorithm will be developed to assist clinicians to make accurate diagnoses. - Capacities to conduct clinical research are measured by the number of capable and trained (GCP) research assistants and investigators; the number of clinical research procedural (SOPs) implemented. Capacities to conduct diagnostic tests are measured by the number of diagnostic test (rapid, serology and molecular test) that are available on sites. - Implementation of specimen’s repository management using laboratory information management system (LIMS) onsite, implementation of quality assurance procedures, the availability of equipment (freezer, collecting and processing equipment and supplies). - |
| Descriptive Information | |
| Judul Penelitian Popular | INA101: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE) |
| Judul Penelitian Ilmiah | The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND) |
| Jenis Penelitian | Observasional |
| Intervensi | N/A |
| Jumlah Subyek Penelitian | 1600 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Inclusion criteria: • Age ≥1 year • Acute febrile illness requiring hospitalization (fever defined as temperature recorded ≥38.0°C during the first 24 hour period of hospitalization). • Hospitalized within the past 24 hours. • Willing to allow storage of blood and other specimens for use in future studies of infectious diseases.Exclusion Criteria: Exclusion criterion • Hospitalized within the past 3 months, not including current hospitalization for acute febrile illness. • Inpatient transfer from another hospital. • A known medical disorder or other circumstance, which in the opinion of the PI might make the participation of the individual unsafe or difficult. Examples include, but not limited to: mental illness which could affect compliance with protocol, an anemic patient preventing blood draw. |
| Administrative Information | |
| Nomor Persetujuan Etik | KE.01.05/EC/407/2012 |
| Nomor Persetujuan Material Transfer Agreement | - |
| Nomor Persetujuan Pelaksanaan Uji Klinik | - |
| Other Study ID Numbers | INA101 |
| Contact Person | Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI |