The Etiology of Acute Febrile Illness Requiring Hospitalization

Acute Febrile Illness Clinical Trial

— AFIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763462
• Other study ID #: INA101
• Secondary ID: U1111-1263-2248H
• Status: Completed
• Start date: July 2013
• Est. completion date: August 2017

Study information

• Verified date: May 2023
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1492
• Est. completion date: August 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Febrile Illness
• Fever
• Hyperthermia

Locations

Country	Name	City	State
Indonesia	University of Padjajaran/ Dr. Hasan Sadikin Hospital	Bandung	West Java
Indonesia	University of Udayana/Sanglah Hospital	Denpasar	Bali
Indonesia	Penyakit Infeksi Sulianti Saroso Hospital	Jakarta	DKI Jakarta
Indonesia	University of Indonesia/ Dr. Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta
Indonesia	University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital	Makassar
Indonesia	University of Diponegoro/ Dr. Kariadi Hospital	Semarang	Central Java
Indonesia	University of Airlangga/ Dr. Soetomo Hospital	Surabaya	East Java
Indonesia	University of Gadjah Mada/ Dr. Sardjito Hospital	Yogyakarta

Sponsors (3)

Lead Sponsor	Collaborator
Ina-Respond	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.	Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular.	Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Secondary	Number of Participants With Affected Organ System by Each Specific Pathogen	The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.	3 years
Secondary	Number of Participants Enrolled Per Each Clinical Research Site	Eight clinical research sites in 7 cities in Indonesia have been established to conduct clinical research that improved research capacity and networking for Infectious diseases in Indonesia.	3 years
Secondary	Number of Vials Stored Based on Specimen Type	Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.	3 years