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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-1317 | Other Identifier | WHO UTN Number |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | at least 7-14 days after enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Muhammad Karyana, MPH | National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 520: University of Udayana/Sanglah Hospital | Denpasar | Bali | 80114 | Indonesia | ||
| Site 560: University of Diponegoro/ Dr. Kariadi Hospital |
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Enrolment period was from November 2020 through July 2022. The study was done at 2 hospitals in Indonesia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suspected COVID-19 Cases | Hospitalized participants with suspected COVID-19 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 5, 2021 |
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whole blood, sputum, urine, stool, nasopharyngeal swab
| Semarang |
| Central of Java |
| 50244 |
| Indonesia |
| Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia |
| Site 540: Penyakit Infeksi Sulianti Saroso Hospital | Jakarta | DKI Jakarta | 14340 | Indonesia |
| Site 590: Persahabatan Hospital | Jakarta | DKI Jakarta | 14340 | Indonesia |
| Site 660 RSUD Abdul Wahab Sjahranie | Samarinda | East Kalimantan | 75123 | Indonesia |
| Site 700 - RSUD Dr.TC Hillers | Maumere | East Nusa Tenggara | 86113 | Indonesia |
| Site 570: University of Airlangga/ Dr. Soetomo Hospital | Surabaya | East of Java | 60286 | Indonesia |
| Site 600 : Adam Malik Hospital | Medan | North Sumatra | 20136 | Indonesia |
| Site 650: Budi Kemuliaan Hospital | Batam | Riau Islands | Indonesia |
| Site 630: M. Ansari Saleh Hospital | Banjarmasin | South Kalimantan | 70125 | Indonesia |
| Site 690 - RSUD Abepura | Jayapura | Special Region of Papua | 99351 | Indonesia |
| Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital | Bandung | West Java | 40161 | Indonesia |
| Site 610 : RSU Kabupaten Tangerang | Tangerang | West Java | 15111 | Indonesia |
| Site 680 - RSUD dr Soedarso | Pontianak | West Kalimantan | 78111 | Indonesia |
| Site 670 - RSUD Dr. Zainoel Abidin | Banda Aceh | 24415 | Indonesia |
| Site 640: St. Carolus Hospital | Jakarta | 10440 | Indonesia |
| Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital | Makassar | 90245 | Indonesia |
| Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital | Yogyakarta | 55284 | Indonesia |
| COMPLETED |
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| NOT COMPLETED |
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Hospitalized participants with suspected COVID-19
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| ID | Title | Description |
|---|---|---|
| BG000 | Suspected COVID-19 Cases | Hospitalized participants with suspected COVID-19 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | at least 7-14 days after enrolment |
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48 hours after blood drawn or specimen collection up to 14 days
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw or specimen collection that is possibly, probably, or definitely related to the blood drawn or specimen collection. Any event outside of this 48 hours window period will not be considered an AE for this study.
All death cases which were not related to the study-related blood draw or specimen collection will not reported either as AE nor SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suspected COVID-19 Cases | Hospitalized participants with suspected COVID-19 | 5 | 185 | 0 | 185 | 0 | 185 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Publication Division | INA-RESPOND | +62214208693 | inapublikasi@ina-respond.net |
| Dec 21, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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