Infectious Disease
Conditions
Keywords
Infectious Disease
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 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.
Interventions
None listed
Sponsors
Ina-Respond
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology 2. Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test) 3. Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test) 4. Able to provide a documented informed consent 5. Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research) 6. For Ongoing patients in outbreak situations: Referral from the MoH as part of a suspected or identified outbreak of infectious disease
Exclusion criteria
* Investigators' discretion for patient safety and well being
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm Etiologies Among Suspected COVID-19 Cases | 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. |
Countries
Indonesia
Participant flow
Recruitment details
Enrolment period was from November 2020 through July 2022. The study was done at 2 hospitals in Indonesia.
Participants by arm
| Arm | Count |
|---|---|
| Suspected COVID-19 Cases Hospitalized participants with suspected COVID-19 | 185 |
| Total | 185 |
Baseline characteristics
| Characteristic | Suspected COVID-19 Cases |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants |
| Age, Continuous | 45 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 185 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Indonesia | 185 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 185 |
| other Total, other adverse events | 0 / 185 |
| serious Total, serious adverse events | 0 / 185 |
Outcome results
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.
Time frame: at least 7-14 days after enrolment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suspected COVID-19 Cases | Confirm Etiologies Among Suspected COVID-19 Cases | SARS CoV-2 | 151 Participants |
| Suspected COVID-19 Cases | Confirm Etiologies Among Suspected COVID-19 Cases | Other pathogens: | 21 Participants |
| Suspected COVID-19 Cases | Confirm Etiologies Among Suspected COVID-19 Cases | Unidentified pathogens | 13 Participants |