Dengue FeverNCT00688389
Investigation of the Immuno-regulation and Viral Hepatitis Among Patients With or After Dengue Fever Infection
An observational study of Dengue Fever, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to 31 Dec 2020
- 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: The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.
Who may be able to join
- Clinical diagnosis of Dengue fever
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Jih-Jin Tsai, MD, 886-7-312-1101 ext. 5677, jijits@cc.kmu.edu.tw
About this study
Official title: Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection
The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.
Read the detailed description
Research has showed that CLEC5A interacts with dengue virion directly, and is responsible for dengue virus (DV)-induced DAP12 phosphorylation. Data suggests that CLEC5A is a potential therapeutic target for dengue hemorrhagic fever (DHF)/dengue shock syndrome (DSS). This project will study the genes of CLEC5A, Mannose receptor, DC-SIGN, NALP, decoy receptor 3 (DcR3), Toll-like receptors(TLRs), and (Nod)-like receptors (NLRs) for both DF and DHF groups. In addition, serum level of decoy receptor 3 (DcR3) will be tested. The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.
- Conditions
- Dengue Fever
- Being tested
- case/control
- Keywords
- Dengue fever, CLEC5A, Mannose receptor, DC-SIGN, NALP,, decoy receptor 3 (DcR3), Toll-like receptors(TLRs),, (Nod)-like receptors (NLRs)
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case/controlOther
case: infected dengue fever people control:healthy people
| Study group | Role | What they receive |
|---|---|---|
| healthy | Not described Receives: Other: case/control | |
| DF | Not described Receives: Other: case/control | |
| DHF | Not described Receives: Other: case/control |
What is being measured
The primary outcome is the main question the study is designed to answer.
檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致
抽血20 c.c 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致
Measured: 2007/7/1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJul 2007
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688389
- Sponsor's protocol ID
- KMUH-IRB-960195_1
- Other IDs
- CB9615
- Status last verified
- Feb 2019
- First submitted
- 28 May 2008
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection
- ClinicalTrials.gov ID
- NCT00688389
- Acronym / sponsor ID
- KMUH-IRB-960195_1
- Conditions
- Dengue Fever
- Keywords
- Dengue fever, CLEC5A, Mannose receptor, DC-SIGN, NALP,, decoy receptor 3 (DcR3), Toll-like receptors(TLRs),, (Nod)-like receptors (NLRs)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jul 2007
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jun 2008 (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.
The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.
Detailed description
Research has showed that CLEC5A interacts with dengue virion directly, and is responsible for dengue virus (DV)-induced DAP12 phosphorylation. Data suggests that CLEC5A is a potential therapeutic target for dengue hemorrhagic fever (DHF)/dengue shock syndrome (DSS). This project will study the genes of CLEC5A, Mannose receptor, DC-SIGN, NALP, decoy receptor 3 (DcR3), Toll-like receptors(TLRs), and (Nod)-like receptors (NLRs) for both DF and DHF groups. In addition, serum level of decoy receptor 3 (DcR3) will be tested. The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | Other: case/control |
| DF | – | Other: case/control |
| DHF | – | Other: case/control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Dengue fever
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case/controlcase: infected dengue fever people control:healthy people | Other | DF, DHF, healthy |
Primary outcome
檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致
Time frame: 2007/7/1
抽血20 c.c 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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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.
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 Dengue Fever, 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 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jih-Jin Tsai, MD (886-7-312-1101 ext. 5677, jijits@cc.kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致 (time frame: 2007/7/1). 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 28 Feb 2019.