Chikungunya FeverNCT02174341
The Pilot Study of Chikungunya Virus Infections in Southern Taiwan
An observational study of Chikungunya Fever, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Fever
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Jul 2018
- 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
- Suspected of being infected with dengue fever
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: Investigate the Prevalence of Serum Chikungunya Virus Infection, and Against Those Suspected Dengue Fever, Chikungunya Disease-related Tests Conducted
This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to detect Chikungunya virus and then develop.
Read the detailed description
During the execution of this project was ended March 1, 2012 to December 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. And closed the case into prospective and retrospective analysis of the last sample into two parts.
Case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and Chikungunya disease associated serum antigen-antibody reaction , PCR (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. In addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (KMUH-IRB-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.
- Conditions
- Chikungunya Fever
- Keywords
- Chikungunya fever, Chikungunya Virus
- Medical subject headings
- Chikungunya Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
For persons with suspected dengue fever, Chikungunya disease-related testing conducted to clarify the clinical dengue and Chikungunya disease of judgment
The project expects to help physicians understand overview of Taiwan Chikungunya epidemic diseases and assisting their clinical judgment. Hope to establish a complete ilk disease and clinical information, and then establish a rapid detection of Chikungunya virus.
Measured: 75 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya 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
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174341
- Sponsor's protocol ID
- KMUH-IRB-20110428
- Status last verified
- Feb 2019
- First submitted
- 20 Jun 2014
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Prevalence of Serum Chikungunya Virus Infection, and Against Those Suspected Dengue Fever, Chikungunya Disease-related Tests Conducted
- ClinicalTrials.gov ID
- NCT02174341
- Acronym / sponsor ID
- KMUH-IRB-20110428
- Conditions
- Chikungunya Fever
- Keywords
- Chikungunya fever, Chikungunya Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Jun 2014 (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.
This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to detect Chikungunya virus and then develop.
Detailed description
During the execution of this project was ended March 1, 2012 to December 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. And closed the case into prospective and retrospective analysis of the last sample into two parts.
Case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and Chikungunya disease associated serum antigen-antibody reaction , PCR (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. In addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (KMUH-IRB-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.
Study design
- Observational model
- Case-control
- Time perspective
- Other
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)
- Suspected of being infected with 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.
Primary outcome
For persons with suspected dengue fever, Chikungunya disease-related testing conducted to clarify the clinical dengue and Chikungunya disease of judgment
Time frame: 75 months
The project expects to help physicians understand overview of Taiwan Chikungunya epidemic diseases and assisting their clinical judgment. Hope to establish a complete ilk disease and clinical information, and then establish a rapid detection of Chikungunya virus.
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 1 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chikungunya 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: finished, as of the sponsor's last update on 1 Mar 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?
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?
For persons with suspected dengue fever, Chikungunya disease-related testing conducted to clarify the clinical dengue and Chikungunya disease of judgment (time frame: 75 months). 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 1 Mar 2019.