The Etiology of Acute Febrile Illness Requiring Hospitalization — AFIRE  

Acute Febrile Illness Clinical Trial

Official title: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)

Status Completed

Clinical Trial Summary

This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Potential study patients will be any patients (both children and adults).

Clinical Trial Description

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:

1. To provide clinical data that are essential for improving and/or developing clinical management and health policies.

2. To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health.

3. 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. ;

Related Conditions & MeSH terms

• Acute Febrile Illness
• Fever
• Hyperthermia

• NCT number: NCT02763462
• Study type: Observational
• Source: Ina-Respond
• Status: Completed
• Start date: July 2013
• Completion date: August 2017