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

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.

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Key information

Conditions

Infectious Disease Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 520: University of Udayana/Sanglah Hospital, Denpasar, Bali, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Confirm Etiologies Among Suspected COVID-19 Cases

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ina-Respond

Other

Registry information

Official study title

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

Acronym: INA-ORCHID

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 9, 2020
Registry last updated: Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed