Clinical trial NCT04339179: Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Official title: INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Keywords: Infectious Disease
Lead sponsor: Ina-Respond
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult or child of any age, both men and women hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology or referral from the MoH as part of a suspected or identified outbreak of infectious disease from 19 active INA-RESPOND Network sites across Indonesia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirm Etiologies Among Suspected COVID-19 Cases
timeFrame: at least 7-14 days after enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Site 520: University of Udayana/Sanglah Hospital
state: Bali
city: Semarang
country: Indonesia
facility: Site 560: University of Diponegoro/ Dr. Kariadi Hospital
state: Central Of Java
city: Jakarta
country: Indonesia
facility: Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Site 540: Penyakit Infeksi Sulianti Saroso Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Site 590: Persahabatan Hospital
state: DKI Jakarta
city: Samarinda
country: Indonesia
facility: Site 660 RSUD Abdul Wahab Sjahranie
state: East Kalimantan
city: Maumere
country: Indonesia
facility: Site 700 - RSUD Dr.TC Hillers
state: East Nusa Tenggara
city: Surabaya
country: Indonesia
facility: Site 570: University of Airlangga/ Dr. Soetomo Hospital
state: East Of Java
city: Medan
country: Indonesia
facility: Site 600 : Adam Malik Hospital
state: North Sumatra
city: Jayapura
country: Indonesia
facility: Site 690 - RSUD Abepura
state: Papua
city: Batam
country: Indonesia
facility: Site 650: Budi Kemuliaan Hospital
state: Riau Islands
city: Banjarmasin
country: Indonesia
facility: Site 630: M. Ansari Saleh Hospital
state: South Kalimantan
city: Bandung
country: Indonesia
facility: Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
state: West Java
city: Tangerang
country: Indonesia
facility: Site 610 : RSU Kabupaten Tangerang
state: West Java
city: Pontianak
country: Indonesia
facility: Site 680 - RSUD dr Soedarso
state: West Kalimantan
city: Banda Aceh
country: Indonesia
facility: Site 670 - RSUD Dr. Zainoel Abidin
city: Jakarta
country: Indonesia
facility: Site 640: St. Carolus Hospital
city: Makassar
country: Indonesia
facility: Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
city: Yogyakarta
country: Indonesia
facility: Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Study officials:
affiliation: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Dr. Muhammad Karyana, MPH
role: PRINCIPAL_INVESTIGATOR
References: