Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04339179
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2020-04-06
Brief Title:
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Sponsor:
Ina-Respond
Organization:
Ina-Respond
Study Overview
Official Title:
INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INA-ORCHID
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
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 facilitiesinstitutions 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
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 facilitiesinstitutions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1263-1317 | OTHER | WHO UTN Number | None |