The Etiology of Acute Febrile Illness Requiring Hospitalization

Completed

• Conditions: Acute Febrile Illness

• Registration Number: NCT02763462
• Lead Sponsor: Ina-Respond

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2016-10
• Study Completion: 2017-08
• Results First Submitted: 2022-09-01
• Results First Submitted QC: 2023-02-01
• Results First Posted: 2023-02-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1492

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.	Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Affected Organ System by Each Specific Pathogen	3 years	The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
Number of Participants Enrolled Per Each Clinical Research Site	3 years	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.
Number of Vials Stored Based on Specimen Type	3 years	Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.

Trial Locations

Locations (8)

University of Diponegoro/ Dr. Kariadi Hospital; 🇮🇩 Semarang, Central Java, Indonesia

University of Airlangga/ Dr. Soetomo Hospital; 🇮🇩 Surabaya, East Java, Indonesia

University of Indonesia/ Dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital; 🇮🇩 Makassar, Indonesia

University of Udayana/Sanglah Hospital; 🇮🇩 Denpasar, Bali, Indonesia

Penyakit Infeksi Sulianti Saroso Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

University of Padjajaran/ Dr. Hasan Sadikin Hospital; 🇮🇩 Bandung, West Java, Indonesia

University of Gadjah Mada/ Dr. Sardjito Hospital; 🇮🇩 Yogyakarta, Indonesia