Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

Study Overview
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Brief Summary
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This observational study will investigate suspected infectious diseases of unknown etiology prospectively during outbreaks and at healthcare facilities, and retrospectively through historical samples where no etiology was ever determined. The study is designed to rapidly, flexibly, and consistently respond to any potential scenario in Indonesia, and the data collected will provide needed insight into the landscape of infectious diseases in the country. By better understanding the infectious causes of outbreaks and difficult hospitalized cases, the Indonesian Ministry of Health will be able to more accurately and efficiently control infectious diseases and craft healthcare policies.

Detailed Description
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This is a study to identify the causative agents and describe the clinical characteristics of infectious disease outbreaks and difficult cases of unidentified etiology in Indonesia. It is a retrospective and prospective observational study with an exploratory design. There will be no intervention to the participants that is intended to affect their SoC or clinical outcome. Retrospective study activities will be ongoing throughout the duration of the study. The INA-RESPOND Reference Lab will perform research tests on various specimens collected as part of historical outbreaks and previous difficult cases where an etiology was never identified. Prospective study activities will be initiated upon official request from health authorities and health facilities/institutions. Requests are expected to be filtered through and evaluated by the 19 active INA-RESPOND Network sites before inclusion in the study. Samples collected during outbreaks and from difficult cases of unknown etiology will be analyzed at the INA-RESPOND Reference Lab at their own pace. Results from any research tests will be shared with the requesting authorities as research-use-only and are not intended to alter standard of care.

Official Title
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INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

Conditions
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Infectious Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test) Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test) Able to provide a documented informed consent Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research) For Ongoing patients in outbreak situations: Referral from the MoH as part of a suspected or identified outbreak of infectious disease Exclusion Criteria: Investigators' discretion for patient safety and well being
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the causative agents and describe the clinical characteristics of presumptive infections reported during infectious diseases outbreaks or referred from difficult cases of unidentified etiology in Indonesia. | The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects. | [Time Frame: 5 years] [No Safety Issue] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the disease course and case management of the presumptive infections | Signs, symptoms, and clinical laboratory data from each confirmed diagnosis calculated in percentages. | [Time Frame: 5 years] [No Safety Issue] | 
| To assess the accuracy of diagnostic tests of the presumptive infections | The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by both point-of-care diagnostic tests and Reference Laboratory tests expressed as ratios. | [Time Frame: 5 years] [No Safety Issue] | 
| To assess treatments and short-term outcomes of the presumptive infections | Enrolled subject condition at end of study and duration of illness from enrollment to end of study. | [Time Frame: 5 years] [No Safety Issue] | 
| To generate epidemiologic data to inform ongoing and future disease control and prevention efforts | The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects. | [Time Frame: 5 years] [No Safety Issue] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infectious Disease