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

Infectious Disease Clinical Trial

— INA-ORCHID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339179
• Other study ID #: INA107
• Secondary ID: U1111-1263-1317
• Status: Recruiting
• Start date: November 18, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Ina-Respond
• Contact: Dr. Muhammad Karyana, MPH
• Phone: +62 21 42879189
• Email: m.karyana[@]ina-respond.net
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Locations

Country	Name	City	State
Indonesia	Site 670 - RSUD Dr. Zainoel Abidin	Banda Aceh
Indonesia	Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital	Bandung	West Java
Indonesia	Site 630: M. Ansari Saleh Hospital	Banjarmasin	South Kalimantan
Indonesia	Site 650: Budi Kemuliaan Hospital	Batam	Riau Islands
Indonesia	Site 520: University of Udayana/Sanglah Hospital	Denpasar	Bali
Indonesia	Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta
Indonesia	Site 540: Penyakit Infeksi Sulianti Saroso Hospital	Jakarta	DKI Jakarta
Indonesia	Site 590: Persahabatan Hospital	Jakarta	DKI Jakarta
Indonesia	Site 640: St. Carolus Hospital	Jakarta
Indonesia	Site 690 - RSUD Abepura	Jayapura	Papua
Indonesia	Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital	Makassar
Indonesia	Site 700 - RSUD Dr.TC Hillers	Maumere	East Nusa Tenggara
Indonesia	Site 600 : Adam Malik Hospital	Medan	North Sumatra
Indonesia	Site 680 - RSUD dr Soedarso	Pontianak	West Kalimantan
Indonesia	Site 660 RSUD Abdul Wahab Sjahranie	Samarinda	East Kalimantan
Indonesia	Site 560: University of Diponegoro/ Dr. Kariadi Hospital	Semarang	Central Of Java
Indonesia	Site 570: University of Airlangga/ Dr. Soetomo Hospital	Surabaya	East Of Java
Indonesia	Site 610 : RSU Kabupaten Tangerang	Tangerang	West Java
Indonesia	Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital	Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Ina-Respond

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects.	[Time Frame: 5 years] [No Safety Issue]
Secondary	To describe the disease course and case management of the presumptive infections	Signs, symptoms, and clinical laboratory data from each confirmed diagnosis calculated in percentages.	[Time Frame: 5 years] [No Safety Issue]
Secondary	To assess the accuracy of diagnostic tests of the presumptive infections	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.	[Time Frame: 5 years] [No Safety Issue]
Secondary	To assess treatments and short-term outcomes of the presumptive infections	Enrolled subject condition at end of study and duration of illness from enrollment to end of study.	[Time Frame: 5 years] [No Safety Issue]
Secondary	To generate epidemiologic data to inform ongoing and future disease control and prevention efforts	The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects.	[Time Frame: 5 years] [No Safety Issue]