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

July 7, 2024 updated by: Ina-Respond

INA-RESPOND 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.

Study Overview

Status

Completed

Conditions

Infectious Disease

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.

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Indonesia
- - Banda Aceh, Indonesia, 24415
    - Site 670 - RSUD Dr. Zainoel Abidin
  - Jakarta, Indonesia, 10440
    - Site 640: St. Carolus Hospital
  - Makassar, Indonesia, 90245
    - Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
  - Yogyakarta, Indonesia, 55284
    - Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
- Bali
  - Denpasar, Bali, Indonesia, 80114
    - Site 520: University of Udayana/Sanglah Hospital
- Central Of Java
  - Semarang, Central Of Java, Indonesia, 50244
    - Site 560: University of Diponegoro/ Dr. Kariadi Hospital
- DKI Jakarta
  - Jakarta, DKI Jakarta, Indonesia, 10430
    - Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
  - Jakarta, DKI Jakarta, Indonesia, 14340
    - Site 540: Penyakit Infeksi Sulianti Saroso Hospital
  - Jakarta, DKI Jakarta, Indonesia, 14340
    - Site 590: Persahabatan Hospital
- East Kalimantan
  - Samarinda, East Kalimantan, Indonesia, 75123
    - Site 660 RSUD Abdul Wahab Sjahranie
- East Nusa Tenggara
  - Maumere, East Nusa Tenggara, Indonesia, 86113
    - Site 700 - RSUD Dr.TC Hillers
- East Of Java
  - Surabaya, East Of Java, Indonesia, 60286
    - Site 570: University of Airlangga/ Dr. Soetomo Hospital
- North Sumatra
  - Medan, North Sumatra, Indonesia, 20136
    - Site 600 : Adam Malik Hospital
- Papua
  - Jayapura, Papua, Indonesia, 99351
    - Site 690 - RSUD Abepura
- Riau Islands
  - Batam, Riau Islands, Indonesia
    - Site 650: Budi Kemuliaan Hospital
- South Kalimantan
  - Banjarmasin, South Kalimantan, Indonesia, 70125
    - Site 630: M. Ansari Saleh Hospital
- West Java
  - Bandung, West Java, Indonesia, 40161
    - Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
  - Tangerang, West Java, Indonesia, 15111
    - Site 610 : RSU Kabupaten Tangerang
- West Kalimantan
  - Pontianak, West Kalimantan, Indonesia, 78111
    - Site 680 - RSUD dr Soedarso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adult or child of any age, both men and women hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology or referral from the MoH as part of a suspected or identified outbreak of infectious disease from 19 active INA-RESPOND Network sites across Indonesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at least 7-14 days after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the disease course and case management of the presumptive infections Time Frame: [Time Frame: 5 years] [No Safety Issue]	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 Time Frame: [Time Frame: 5 years] [No Safety Issue]	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 Time Frame: [Time Frame: 5 years] [No Safety Issue]	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 Time Frame: [Time Frame: 5 years] [No Safety Issue]	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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ina-Respond

Investigators

Principal Investigator: Dr. Muhammad Karyana, MPH, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria