Arbovirus InfectionsNCT01868399
Pilot Survey of Dengue Fever in Solomon Islands
An observational study of Arbovirus Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections
- How many people
- 2,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Mar 2013to 31 Dec 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Residents of Solomon Islands * people who understand the purpose of the study * people who agree to sign the informed consent
Who may be able to join
- healthy volunteer
- reported dengue virus infection volunteer
- people who understand the purpose of the study and agree the to sign the informed consent
Who cannot join
- people who refuse to join the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arbovirus Infections
- Keywords
- dengue virus
- Medical subject headings
- Arbovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected dengue fever subjects | No any intervention | |
| Community Healty Residents | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dengue fever
Clinical manifestations, comorbidity and severity
Measured: at the time of sampling (blood)
Secondary outcomes (1)
Co-infection and interplay of dengue-like pathogens
Identification and Analysis of dengue-like illness and pathogens to investigate the interplay between these coinfections
Measured: within the first 3 months after blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start22 Mar 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Foreign Affairs, Republic of China, TAIWAN, Ministry of Health and Medical Services, Solomon Islands, National Referral Hospital
- Responsible party
- Principal investigator, Wen-Ter Lai (20120080), Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Wen-Ter Lai, MD, Study chair, Kaohsiung Medical University Chung-Ho Memorial HospitalJih-Jin Tsai, MD, Ph. D., Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868399
- Sponsor's protocol ID
- KMUH-IRB-20120080
- Status last verified
- Aug 2016
- First submitted
- 27 May 2013
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Survey of Dengue Fever in Solomon Islands
- ClinicalTrials.gov ID
- NCT01868399
- Acronym / sponsor ID
- KMUH-IRB-20120080
- Conditions
- Arbovirus Infections
- Keywords
- dengue virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Foreign Affairs, Republic of China, TAIWAN, Ministry of Health and Medical Services, Solomon Islands, National Referral Hospital
- Study start
- 22 Mar 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected dengue fever subjects | – | –No any intervention |
| Community Healty Residents | – | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Residents of Solomon Islands * people who understand the purpose of the study * people who agree to sign the informed consent
Key inclusion criteria (3 listed)
- healthy volunteer
- reported dengue virus infection volunteer
- people who understand the purpose of the study and agree the to sign the informed consent
Key exclusion criteria (1 listed)
- people who refuse to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dengue fever
Time frame: at the time of sampling (blood)
Clinical manifestations, comorbidity and severity
1 secondary outcome
Co-infection and interplay of dengue-like pathogens
Time frame: within the first 3 months after blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Ter Lai, MD study chair
Kaohsiung Medical University Chung-Ho Memorial Hospital
Jih-Jin Tsai, MD, Ph. D. principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arbovirus Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dengue fever (time frame: at the time of sampling (blood)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.