Dengue FeverNCT02608047
Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou
An observational study of Dengue Fever, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dengue patients
Who may be able to join
- Dengue patients confirmed by dengue virus NS1 or RNA
Who cannot join
- Pregnant women
- Fever diseases caused by other viruses
- Combined bacterial infection
- Without complications such as diabetes and tumor.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou NO 8. people's hospital
Guangzhou, Guangdong, 510060
Fuchun Zhang, 8620-83710219, gz8hzfc@126.com
Lingzhai Zhao, 8620-83866127, gz8hzlz@126.com
About this study
The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.
Read the detailed description
To study the epidemiological and pathogenic of dengue virus in Guangzhou, which help to reveal the regular prevalent pattern and the natural epidemic focus of dengue fever. To establish dengue virus sequence database of Guangzhou region, research the biological characteristics and molecular characteristics of dengue fever epidemic strains especially in 2014 in Guangzhou region, to determine the source and variation of this epidemic strains , which finally help to reveal the cause of the pandemic.
To investigate the serum epidemiology of 7800 large groups of people in 12 county-level cities in Guangzhou by stratified random sampling method. It will enrich the research database of the dengue fever serological antibody level survey of people in Guangzhou. After that the investigators could provide a scientific reference for setting up a risk evaluation and implementation of targeted control measures, and also provide reference for analysis of the epidemic situation in other areas.
To study on molecular markers predictive of severe dengue fever and protective immunity after dengue virus infection. The investigators will obtain both serotype-specific and cross-reactive antibodies, which is highly protective neutralizing antibodies. Then the investigators will explore the potential for clinical application about these neutralizing antibodies. The dengue virus were sequenced which caused dengue fever or severe dengue fever in 2014, and do bioinformatics analysis to find the genetic loci which may be responsible for virulence of dengue virus.
To sum up the clinical and laboratory data of dengue fever in 2014, to carry out the research on the diagnosis and treatment of dengue fever, to explore the effectiveness, safety and mechanism of Integrated Chinese and Western medicine treatment for dengue fever patients，to establish of a more perfect system for the diagnosis and treatment of dengue fever in China.
- Conditions
- Dengue Fever
- Medical subject headings
- Dengue
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 |
|---|---|---|
| dengue patients | Dengue patients confirmed by Non-structural protein and RNA | |
| Healthy controls | Healthy population without any diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause severe dengue
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (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.
- 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuchun Zhang, Guangzhou 8th People's Hospital
- Investigators
- Fuchun Zhang, Principal investigator, Guangzhou NO 8. people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608047
- Sponsor's protocol ID
- 201508020263
- Status last verified
- Nov 2015
- First submitted
- 11 Oct 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou
- ClinicalTrials.gov ID
- NCT02608047
- Acronym / sponsor ID
- 201508020263
- Conditions
- Dengue Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Nov 2015 (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 purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.
Detailed description
To study the epidemiological and pathogenic of dengue virus in Guangzhou, which help to reveal the regular prevalent pattern and the natural epidemic focus of dengue fever. To establish dengue virus sequence database of Guangzhou region, research the biological characteristics and molecular characteristics of dengue fever epidemic strains especially in 2014 in Guangzhou region, to determine the source and variation of this epidemic strains , which finally help to reveal the cause of the pandemic.
To investigate the serum epidemiology of 7800 large groups of people in 12 county-level cities in Guangzhou by stratified random sampling method. It will enrich the research database of the dengue fever serological antibody level survey of people in Guangzhou. After that the investigators could provide a scientific reference for setting up a risk evaluation and implementation of targeted control measures, and also provide reference for analysis of the epidemic situation in other areas.
To study on molecular markers predictive of severe dengue fever and protective immunity after dengue virus infection. The investigators will obtain both serotype-specific and cross-reactive antibodies, which is highly protective neutralizing antibodies. Then the investigators will explore the potential for clinical application about these neutralizing antibodies. The dengue virus were sequenced which caused dengue fever or severe dengue fever in 2014, and do bioinformatics analysis to find the genetic loci which may be responsible for virulence of dengue virus.
To sum up the clinical and laboratory data of dengue fever in 2014, to carry out the research on the diagnosis and treatment of dengue fever, to explore the effectiveness, safety and mechanism of Integrated Chinese and Western medicine treatment for dengue fever patients，to establish of a more perfect system for the diagnosis and treatment of dengue fever in China.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dengue patients | – | –Dengue patients confirmed by Non-structural protein and RNA |
| Healthy controls | – | –Healthy population without any diseases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dengue patients
Key inclusion criteria (1 listed)
- Dengue patients confirmed by dengue virus NS1 or RNA
Key exclusion criteria (4 listed)
- Pregnant women
- Fever diseases caused by other viruses
- Combined bacterial infection
- Without complications such as diabetes and tumor.
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
All cause severe dengue
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
Fuchun Zhang principal investigator
Guangzhou NO 8. people's 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 Dengue Fever, run by Guangzhou 8th People's Hospital at 1 site in China.
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 4 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 18 Nov 2015. 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 China. 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 Fuchun Zhang, doctor (8620-83710219, gz8hzfc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause severe dengue (time frame: One year). 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 18 Nov 2015.