Infectious Disease Clinical Trial
— INA-ORCHIDOfficial title:
INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ina-Respond |
Indonesia,
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] |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05568953 -
An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
|
Phase 2 | |
Completed |
NCT04568889 -
Minnesota COVID-19 Testing Project
|
N/A | |
Completed |
NCT06063330 -
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
|
Phase 1 | |
Completed |
NCT01198925 -
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
|
Phase 4 | |
Completed |
NCT05063812 -
Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
|
||
Not yet recruiting |
NCT03636711 -
Antibiotic Stewardship in Infectious Disease Departement
|
||
Completed |
NCT03457688 -
Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
|
N/A | |
Completed |
NCT03241355 -
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
|
N/A | |
Terminated |
NCT05420077 -
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273
|
Phase 1 | |
Completed |
NCT04084106 -
Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota
|
Phase 4 | |
Recruiting |
NCT05013944 -
AnovaOS Network Powered Patient Registry
|
||
Completed |
NCT03893279 -
Perception of Smell and Taste During Antibiotic Treatment
|
||
Active, not recruiting |
NCT05619770 -
Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
|
Phase 1 | |
Completed |
NCT01772901 -
Brief Influenza Vaccine Education to Pregnant Women
|
N/A | |
Completed |
NCT05413772 -
Temocillin in ESBL-Enterobacteriaceae Infections
|
||
Completed |
NCT04319328 -
Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
|
||
Completed |
NCT04613271 -
Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
|
Phase 3 | |
Completed |
NCT03239665 -
Vaccination Education Through Pharmacists and Senior Centers (VEPSC)
|
N/A | |
Completed |
NCT03224026 -
Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source
|
||
Not yet recruiting |
NCT06102070 -
Genetic Susceptibility to Severe Infections
|