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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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Site 520: University of Udayana/Sanglah Hospital
Denpasar, Bali, Indonesia
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central of Java, Indonesia
Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia
Site 540: Penyakit Infeksi Sulianti Saroso Hospital
Jakarta, DKI Jakarta, Indonesia
Site 590: Persahabatan Hospital
Jakarta, DKI Jakarta, Indonesia
Site 660 RSUD Abdul Wahab Sjahranie
Samarinda, East Kalimantan, Indonesia
Site 700 - RSUD Dr.TC Hillers
Maumere, East Nusa Tenggara, Indonesia
Site 570: University of Airlangga/ Dr. Soetomo Hospital
Surabaya, East of Java, Indonesia
Site 600 : Adam Malik Hospital
Medan, North Sumatra, Indonesia
Site 650: Budi Kemuliaan Hospital
Batam, Riau Islands, Indonesia
Start Date
November 18, 2020
Primary Completion Date
July 1, 2022
Completion Date
July 8, 2022
Last Updated
October 15, 2024
185
ACTUAL participants
Lead Sponsor
Ina-Respond
NCT07069400
NCT07347015
NCT06426147
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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