- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01868399
Pilot Survey of Dengue Fever in Solomon Islands
March 5, 2017 updated by: Wen-Ter Lai (20120080), Kaohsiung Medical University Chung-Ho Memorial Hospital
Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the medical service for people in Solomon Islands thru Taiwan Health Center at the local.
In addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus, Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections might be the existing but overlooked and neglected medical issues in Solomon Islands.
These infections show similarity in clinical manifestations and usually difficulty in clinical diagnosis, instead these infections rely on the laboratory identification with good laboratory quality and facility.
Study Overview
Status
Completed
Conditions
Detailed Description
In this study, the investigators plan to investigate the local people, either from the community or the hospitals, to identify the prevalence and incidence of dengue fever, including laboratory identification of related infections for differential diagnosis, including Japanese Encephalitis virus, Chikungunya virus and intestinal parasitic infections.
Intestinal parasite survey has been the routine long-term service offered by the Kaohsiung Medical University Hospital in Solomon Islands.
At the same time, the subjects enrolled in this study will also be asked the common medical illness in Solomon Islands (i.e.
malaria, pulmonary tuberculosis and metabolic syndrome etc.) in order to delineate the association of dengue fever and these acute and chronic illness.
Study Type
Observational
Enrollment (Actual)
2200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kaohsiung city, Taiwan, 807
- Tropical medicine center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Residents of Solomon Islands
- people who understand the purpose of the study
- people who agree to sign the informed consent
Description
Inclusion Criteria:
- healthy volunteer
- reported dengue virus infection volunteer
- people who understand the purpose of the study and agree the to sign the informed consent
Exclusion Criteria:
- people who refuse to join the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Suspected dengue fever subjects
No any intervention
|
Community Healty Residents
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dengue fever
Time Frame: at the time of sampling (blood)
|
Clinical manifestations, comorbidity and severity
|
at the time of sampling (blood)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Co-infection and interplay of dengue-like pathogens
Time Frame: within the first 3 months after blood sampling
|
Identification and Analysis of dengue-like illness and pathogens to investigate the interplay between these coinfections
|
within the first 3 months after blood sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Wen-Ter Lai, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Principal Investigator: Jih-Jin Tsai, MD, Ph. D., Kaohsiung Medical University Chung-Ho Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 22, 2013
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (Estimate)
June 4, 2013
Study Record Updates
Last Update Posted (Actual)
March 7, 2017
Last Update Submitted That Met QC Criteria
March 5, 2017
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB-20120080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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