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

August 23, 2022 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

Recruiting

Conditions

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 (Anticipated)

2500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Banda Aceh, Indonesia, 24415
        • Not yet recruiting
        • Site 670 - RSUD Dr. Zainoel Abidin
        • Contact:
        • Principal Investigator:
          • Dr. dr. Kurnia Fitri Jamil, M.Kes., Sp.PD-KPTI
      • Jakarta, Indonesia, 10440
        • Not yet recruiting
        • Site 640: St. Carolus Hospital
        • Contact:
        • Principal Investigator:
          • dr. Emon Winardi Danudirgo, SpPD
      • Makassar, Indonesia, 90245
        • Not yet recruiting
        • Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
        • Contact:
        • Principal Investigator:
          • dr. Sudirman Katu SpPD, K-PTI
      • Yogyakarta, Indonesia, 55284
        • Not yet recruiting
        • Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Yanri Subronto PhD, Sp.PD, FINASIM
    • Bali
      • Denpasar, Bali, Indonesia, 80114
        • Not yet recruiting
        • Site 520: University of Udayana/Sanglah Hospital
        • Contact:
        • Principal Investigator:
          • Dr. dr. Agus Somya Sp.PD (KPTI)
    • Central Of Java
      • Semarang, Central Of Java, Indonesia, 50244
        • Not yet recruiting
        • Site 560: University of Diponegoro/ Dr. Kariadi Hospital
        • Contact:
          • Prof. dr. Muhammad Hussein Gasem, PhD, SpPD-KPTI
          • Phone Number: +62248446757
          • Email: mhgasem@yahoo.com
        • Principal Investigator:
          • dr. Nur Farhanah Sp.PD, K-PTI, MSi.Med
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Not yet recruiting
        • Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
        • Contact:
          • Prof. Dr. Pratiwi Sudarmono, PhD, SpMK (K)
          • Phone Number: +62 21 315 59 96
          • Email: psdrmn@yahoo.com
        • Principal Investigator:
          • Dr. dr. Evy Yunihastuti, Sp.PD-KAI
      • Jakarta, DKI Jakarta, Indonesia, 14340
        • Not yet recruiting
        • Site 540: Penyakit Infeksi Sulianti Saroso Hospital
        • Principal Investigator:
          • dr. Adria Rusli, Sp.P
        • Contact:
      • Jakarta, DKI Jakarta, Indonesia, 14340
        • Not yet recruiting
        • Site 590: Persahabatan Hospital
        • Contact:
        • Principal Investigator:
          • Dr. dr. Erlina Burhan, SpP(K), MSc
    • East Kalimantan
      • Samarinda, East Kalimantan, Indonesia, 75123
        • Not yet recruiting
        • Site 660 RSUD Abdul Wahab Sjahranie
        • Contact:
          • Dr. dr. Carta Agrawanto Gunawan, Sp.PD, K-PTI
          • Phone Number: +62 541738118
          • Email: carta_g@yahoo.com
        • Contact:
    • East Nusa Tenggara
      • Maumere, East Nusa Tenggara, Indonesia, 86113
        • Not yet recruiting
        • Site 700 - RSUD Dr.TC Hillers
        • Contact:
        • Principal Investigator:
          • dr. Asep Purnama, Sp.PD
    • East Of Java
      • Surabaya, East Of Java, Indonesia, 60286
        • Not yet recruiting
        • Site 570: University of Airlangga/ Dr. Soetomo Hospital
        • Contact:
        • Principal Investigator:
          • Prof. Dr.Usman Hadi SpPD, KPT
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20136
        • Not yet recruiting
        • Site 600 : Adam Malik Hospital
        • Contact:
        • Principal Investigator:
          • dr. Tambar Kembaren SpPD, K-PTI
    • Papua
      • Jayapura, Papua, Indonesia, 99351
        • Not yet recruiting
        • Site 690 - RSUD Abepura
        • Contact:
        • Principal Investigator:
          • Dr I Made Gede Darmaja, SpPD FINASIM
    • Riau Islands
      • Batam, Riau Islands, Indonesia
        • Not yet recruiting
        • Site 650: Budi Kemuliaan Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Bratasena, Sp.PD, M.Ked
    • South Kalimantan
      • Banjarmasin, South Kalimantan, Indonesia, 70125
        • Not yet recruiting
        • Site 630: M. Ansari Saleh Hospital
        • Contact:
          • dr. Anna Martiana Afida, Sp.PK,MPH
          • Phone Number: +62 511 6710000
        • Contact:
          • Dr. Hj. Wiwit Agung SNC, SPPD.K-Ger
          • Phone Number: +62 511 6710000
        • Principal Investigator:
          • Dr. Hj. Wiwit Agung SNC, SPPD.K-Ger
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Not yet recruiting
        • Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Rudi Wisaksana Sp.PD-KPTI.,Ph.D
      • Tangerang, West Java, Indonesia, 15111
        • Recruiting
        • Site 610 : RSU Kabupaten Tangerang
        • Contact:
        • Principal Investigator:
          • dr. I Gede Rai Kosa, SpPD
        • Sub-Investigator:
          • dr. Arif Budiman, SpA
        • Sub-Investigator:
          • dr. Chakrawati Hayuningsih, SpPK
    • West Kalimantan
      • Pontianak, West Kalimantan, Indonesia, 78111
        • Not yet recruiting
        • Site 680 - RSUD dr Soedarso
        • Contact:
        • Principal Investigator:
          • dr. Ivan Lumban Toruan, Sp.PD

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

No

Genders Eligible for Study

All

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:

  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

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
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: [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]

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 (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INA107
  • U1111-1263-1317 (Other Identifier: WHO UTN Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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