Clinical trial NCT02763462: The Etiology of Acute Febrile Illness Requiring Hospitalization
Official title: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Febrile Illness
Keywords: Acute Febrile Illness
Lead sponsor: Ina-Respond
Sponsor class: OTHER
Collaborators: name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-05-05
Enrollment: 1492
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with acute febrile illness.

Brief 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).

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:

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
timeFrame: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Secondary outcomes:
measure: Number of Participants With Affected Organ System by Each Specific Pathogen
timeFrame: 3 years
measure: Number of Participants Enrolled Per Each Clinical Research Site
timeFrame: 3 years
measure: Number of Vials Stored Based on Specimen Type
timeFrame: 3 years
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: University of Udayana/Sanglah Hospital
state: Bali
city: Semarang
country: Indonesia
facility: University of Diponegoro/ Dr. Kariadi Hospital
state: Central Java
city: Jakarta
country: Indonesia
facility: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Penyakit Infeksi Sulianti Saroso Hospital
state: DKI Jakarta
city: Surabaya
country: Indonesia
facility: University of Airlangga/ Dr. Soetomo Hospital
state: East Java
city: Bandung
country: Indonesia
facility: University of Padjajaran/ Dr. Hasan Sadikin Hospital
state: West Java
city: Makassar
country: Indonesia
facility: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
city: Yogyakarta
country: Indonesia
facility: University of Gadjah Mada/ Dr. Sardjito Hospital
Study officials:
affiliation: University of Diponegoro/ Dr. Kariadi hospital
name: Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHRD, Indonesia
name: Prof. Emiliana Tjitra, MSC, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital
name: Dr. Bachti Alisjahbana, PhD, SpPD-KPTI
role: PRINCIPAL_INVESTIGATOR
References: