Observational Research on Infectious Disease Outbreaks & Difficult Cases

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04339179
Study type	Observational
Source	Ina-Respond
Contact	Dr. Muhammad Karyana, MPH
Phone	+62 21 42879189
Email	m.karyana@ina-respond.net
Status	Recruiting
Phase
Start date	November 18, 2020
Completion date	December 31, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms