Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
INA-RESPOND Network
No Registry
IINA-LWE89BE
Tanggal Input Registry : 01-12-2020

01-12-2020
To identify the causative agents and describe the clinical characteristics of presumptive infections reported during infectious diseases outbreaks or referred from difficult cases of unidentified etiology in Indonesia.
1.To describe the disease course and case management of the presumptive infections Outcome Measures: Signs, symptoms, and clinical laboratory data from each confirmed diagnosis calculated in percentages. 2.To assess the accuracy of diagnostic tests of the presumptive infections Outcome Measures: The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by both point-of-care diagnostic tests and Reference Laboratory tests expressed as ratios. 3.To assess treatments and short-term outcomes of the presumptive infections Outcome Measures: Enrolled subject condition at end of study and duration of illness from enrollment to end of study. 4.To generate epidemiological data to inform ongoing and future disease control and prevention efforts Outcome Measures: The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects.
 
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Observational
This is Observational study without intervention
2500
 

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)

Exclusion Criteria:

Investigators’ discretion for patient safety and well-being
 
No. LB.02.01/2/KE.346/2020
INA107
Dr. Muhammad Karyana, M.Kes