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

Completed

Conditions: Infectious Disease

Registration Number: NCT04339179

Lead Sponsor: Ina-Respond

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirm Etiologies Among Suspected COVID-19 Cases	at least 7-14 days after enrolment	Hospitalized suspected COVID-19 participants were monitored for at least 7-14 days after enrollment. Laboratory tests such as blood culture, RDT Influenza, RDT Dengue, Tubex TF, serology, and molecular were done to identify the etiology.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (19): Site 520: University of Udayana/Sanglah Hospital
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Denpasar, Bali, Indonesia
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
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Semarang, Central Of Java, Indonesia
Site 610 : RSU Kabupaten Tangerang
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Tangerang, West Java, Indonesia
Site 680 - RSUD dr Soedarso
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Pontianak, West Kalimantan, Indonesia
Site 670 - RSUD Dr. Zainoel Abidin
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Banda Aceh, Indonesia
Site 640: St. Carolus Hospital
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Jakarta, Indonesia
Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
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Jakarta, DKI Jakarta, Indonesia
Site 540: Penyakit Infeksi Sulianti Saroso Hospital
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Jakarta, DKI Jakarta, Indonesia
Site 590: Persahabatan Hospital
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Jakarta, DKI Jakarta, Indonesia
Site 660 RSUD Abdul Wahab Sjahranie
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Samarinda, East Kalimantan, Indonesia
Site 570: University of Airlangga/ Dr. Soetomo Hospital
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Surabaya, East Of Java, Indonesia
Site 600 : Adam Malik Hospital
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Medan, North Sumatra, Indonesia
Site 690 - RSUD Abepura
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Jayapura, Papua, Indonesia
Site 650: Budi Kemuliaan Hospital
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Batam, Riau Islands, Indonesia
Site 630: M. Ansari Saleh Hospital
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Banjarmasin, South Kalimantan, Indonesia
Site 700 - RSUD Dr.TC Hillers
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Maumere, East Nusa Tenggara, Indonesia
Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
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Bandung, West Java, Indonesia
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
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Makassar, Indonesia
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
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Yogyakarta, Indonesia