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

Sponsor
Ina-Respond (Other)
Overall Status
Recruiting
CT.gov ID
NCT04339179
Collaborator
(none)
2,500
Enrollment
19
Locations
61
Anticipated Duration (Months)
131.6
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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. [[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.

    Secondary Outcome Measures

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

      Signs, symptoms, and clinical laboratory data from each confirmed diagnosis calculated in percentages.

    2. To assess the accuracy of diagnostic tests of the presumptive infections [[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.

    3. To assess treatments and short-term outcomes of the presumptive infections [[Time Frame: 5 years] [No Safety Issue]]

      Enrolled subject condition at end of study and duration of illness from enrollment to end of study.

    4. To generate epidemiologic data to inform ongoing and future disease control and prevention efforts [[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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology

    2. Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test)

    3. Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test)

    4. Able to provide a documented informed consent

    5. Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research)

    6. 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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Ina-Respond

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ina-Respond
    ClinicalTrials.gov Identifier:
    NCT04339179
    Other Study ID Numbers:
    • INA107
    • U1111-1263-1317
    First Posted:
    Apr 9, 2020
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ina-Respond
    Infectious Disease
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections

    Study Results

    No Results Posted as of Dec 29, 2020