The Etiology of Acute Febrile Illness Requiring Hospitalization

This study is an observational cohort to identify the etiologies of acute febrile illness (less than or equal to 2 weeks), which are thought to be endemic or novel in a certain area. Therefore, there are no hypotheses that require sample size calculation to be tested. It is expected that this study will enroll a minimum of 200 patients per site: approximately 100 adults and 100 pediatric cases. The final sample size is therefore estimated to be 1600.

Primary Objective:

To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes.

Secondary Objectives:

• To provide clinical data that are essential for improving and/or developing clinical management and health policies.
• To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health.
• To establish a repository of biological specimens for future study, such as determining the etiology of undiagnosed fever and/or its pathogenicity and its public health importance.

This study will be conducted at all the INA-RESPOND hospitals (8 hospitals):

• Dr. Cipto Mangunkusumo Hospital , Jakarta
• Penyakit Infeksi Prof. Dr. Sulianti Saroso Hospital, Jakarta
• Dr. Hasan Sadikin Hospital, Bandung
• Dr. Kariadi Hospital, Semarang
• Dr. Sardjito Hospital, Yogyakarta
• Dr. Soetomo Hospital, Surabaya
• Sanglah Hospital, Bali
• Dr. Wahidin Soedirohusodo Hospital, Makassar

The study will enroll eligible fever patients for a period of up to 1 year. Follow-up may be up until one year after last subject is enrolled. Stored samples will be investigated during the study and/or after study completion.

After enrollment, patients will be seen at 14-28 days and at 3 months post enrollment. Patients will be seen every 3 months (6, 9, and 12 months within a window period of +/- 14 days) until cured and no related symptoms persists or the one year time point is reached. The samples will be collected for storage at enrollment, the 14-28 day visit, at 3 months and every 3 months thereafter if not cured.

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

• 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.