N/A
N=185
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Infectious Disease
Bottom Line
View on ClinicalTrials.gov: NCT04339179 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Confirm Etiologies Among Suspected COVID-19 Cases — 151; 21; 13 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ina-Respond
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirm Etiologies Among Suspected COVID-19 Cases |
151; 21; 13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology
- Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test)
- Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test)
- Able to provide a documented informed consent
- Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research)
- 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
Data sourced from ClinicalTrials.gov (NCT04339179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.