Infectious DiseaseINA-ORCHIDNCT04339179
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
An observational study of Infectious Disease, run by Ina-Respond at 19 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease
- How many people
- 185 participants
- Where
- 19 sitesIndonesia
- Study dates
- 18 Nov 2020to 8 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Investigators' discretion for patient safety and well being
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Indonesia19 sites
Site 670 - RSUD Dr. Zainoel Abidin
Banda Aceh, 24415
Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
Bandung, West Java, 40161
Site 630: M. Ansari Saleh Hospital
Banjarmasin, South Kalimantan, 70125
Site 650: Budi Kemuliaan Hospital
Batam, Riau Islands
Site 520: University of Udayana/Sanglah Hospital
Denpasar, Bali, 80114
Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430
Site 540: Penyakit Infeksi Sulianti Saroso Hospital
Jakarta, DKI Jakarta, 14340
Site 590: Persahabatan Hospital
Jakarta, DKI Jakarta, 14340
Site 640: St. Carolus Hospital
Jakarta, 10440
Site 690 - RSUD Abepura
Jayapura, Special Region of Papua, 99351
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, 90245
Site 700 - RSUD Dr.TC Hillers
Maumere, East Nusa Tenggara, 86113
Site 600 : Adam Malik Hospital
Medan, North Sumatra, 20136
Site 680 - RSUD dr Soedarso
Pontianak, West Kalimantan, 78111
Site 660 RSUD Abdul Wahab Sjahranie
Samarinda, East Kalimantan, 75123
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central of Java, 50244
Site 570: University of Airlangga/ Dr. Soetomo Hospital
Surabaya, East of Java, 60286
Site 610 : RSU Kabupaten Tangerang
Tangerang, West Java, 15111
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, 55284
About this study
Official title: 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.
Read the 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.
- Conditions
- Infectious Disease
- Keywords
- Infectious Disease
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm Etiologies Among Suspected COVID-19 Cases
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.
Measured: at least 7-14 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start18 Nov 2020
- Primary completion1 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Muhammad Karyana, MPH, Principal investigator, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339179
- Sponsor's protocol ID
- INA107
- Other IDs
- U1111-1263-1317
- Acronym
- INA-ORCHID
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
- ClinicalTrials.gov ID
- NCT04339179
- Acronym / sponsor ID
- INA-ORCHID / INA107
- Conditions
- Infectious Disease
- Keywords
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Investigators' discretion for patient safety and well being
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Muhammad Karyana, MPH principal investigator
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by Ina-Respond at 19 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm Etiologies Among Suspected COVID-19 Cases (time frame: at least 7-14 days after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.