Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia
NCT ID: NCT04339179
Last Updated: 2024-10-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
185 participants
OBSERVATIONAL
2020-11-18
2022-07-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population
NCT05060562
Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients
NCT03366454
The Etiology of Acute Febrile Illness Requiring Hospitalization
NCT02763462
Study of the Effectiveness of The COVID-19 Vaccine
NCT05766176
Actionable Results: Bloodstream Infection Molecular Assay Evaluation
NCT03255759
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ina-Respond
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Muhammad Karyana, MPH
Role: PRINCIPAL_INVESTIGATOR
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 520: University of Udayana/Sanglah Hospital
Denpasar, Bali, Indonesia
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central of Java, 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 660 RSUD Abdul Wahab Sjahranie
Samarinda, East Kalimantan, Indonesia
Site 700 - RSUD Dr.TC Hillers
Maumere, East Nusa Tenggara, Indonesia
Site 570: University of Airlangga/ Dr. Soetomo Hospital
Surabaya, East of Java, Indonesia
Site 600 : Adam Malik Hospital
Medan, North Sumatra, Indonesia
Site 650: Budi Kemuliaan Hospital
Batam, Riau Islands, Indonesia
Site 630: M. Ansari Saleh Hospital
Banjarmasin, South Kalimantan, Indonesia
Site 690 - RSUD Abepura
Jayapura, Special Region of Papua, Indonesia
Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Site 610 : RSU Kabupaten Tangerang
Tangerang, West Java, Indonesia
Site 680 - RSUD dr Soedarso
Pontianak, West Kalimantan, Indonesia
Site 670 - RSUD Dr. Zainoel Abidin
Banda Aceh, , Indonesia
Site 640: St. Carolus Hospital
Jakarta, , Indonesia
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, , Indonesia
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, , Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1263-1317
Identifier Type: OTHER
Identifier Source: secondary_id
INA107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.