- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02763462
The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE)
The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
Study Overview
Status
Conditions
Detailed 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:
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Makassar, Indonesia, 90245
- University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
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Yogyakarta, Indonesia, 55284
- University of Gadjah Mada/ Dr. Sardjito Hospital
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Bali
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Denpasar, Bali, Indonesia, 80114
- University of Udayana/Sanglah Hospital
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Central Java
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Semarang, Central Java, Indonesia, 50244
- University of Diponegoro/ Dr. Kariadi Hospital
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 10430
- University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
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Jakarta, DKI Jakarta, Indonesia, 14340
- Penyakit Infeksi Sulianti Saroso Hospital
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East Java
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Surabaya, East Java, Indonesia, 60286
- University of Airlangga/ Dr. Soetomo Hospital
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West Java
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Bandung, West Java, Indonesia, 40161
- University of Padjajaran/ Dr. Hasan Sadikin Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Time Frame: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
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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.
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Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Affected Organ System by Each Specific Pathogen
Time Frame: 3 years
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The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
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3 years
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Number of Participants Enrolled Per Each Clinical Research Site
Time Frame: 3 years
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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.
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3 years
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Number of Vials Stored Based on Specimen Type
Time Frame: 3 years
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Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI, University of Diponegoro/ Dr. Kariadi Hospital
- Principal Investigator: Dr. Bachti Alisjahbana, PhD, SpPD-KPTI, Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital
- Principal Investigator: Prof. Emiliana Tjitra, MSC, Ph.D, NIHRD, Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INA101
- HHSN261200800001E (Other Identifier: NIAID)
- U1111-1263-2248 (Other Identifier: WHO UTN Number)
- HHSN261201500003I (Other Identifier: NIAID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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