DengueNCT02606019
The Use of Biomarkers in Predicting Dengue Outcome
An observational study of Dengue, run by Universiti Tunku Abdul Rahman at 2 sites in Malaysia.
Trial summary
The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Dengue
- How many people
- 108 participants
- Where
- 2 sitesMalaysia
- Study dates
- Oct 2015to Oct 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients will be recruited from primary care and followed up in the hospital if they were admitted.
Who may be able to join
- Participants who are age 15 or more.
- Participants must be recruited within the first three days of fever.
- Positive dengue by NS1Ag. Confirmed later on by paired dengue IgM/IgG.
- Final diagnosis of severe dengue or non-severe dengue.
Who cannot join
- Participants who are less than 15 years old.
- Pregnant mothers.
- Participants should not have autoimmune disorder, haematological disorder, cancer, cardiovascular disease, on long term warfarin and aspirin.
- Participants who have been previously treated with dengue infection (secondary dengue infection will be excluded by dengue IgM/IgG).
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites, 2 recruiting
- Recruiting
Ampang Hospital
Ampang, Selangor
Ridzuan Isa, dmiaw2@gmail.com
Rosaida Mohammad Said
- Recruiting
Klinik Kesihatan Ampang (Ampang Health Clinic)
Ampang, Selangor
Hanif Zailani, MPH, hanif@moh.gov.my
About this study
The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.
Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).
Read the detailed description
The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.
Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).
This is a prospective cohort study in which the patient will be followed up from the day of presentation to the attending practitioner until the patient is discharged. The blood samples will be obtained daily during the follow-up. The demography and clinical final diagnosis will be obtained from the medical record of the patient.
This study will aid triaging of dengue cases thereby reducing the need of unnecessary admission and better focused management to those might develop complication of dengue infection. This in turn reduces the workload and cost of the treating the dengue infection.
- Conditions
- Dengue
- Keywords
- Pentraxin 3, Vascular Endothelial Growth Factor, dengue
- Medical subject headings
- Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (%) of biomarkers (PTX3 and VEGF)
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Measured: upon study completion, 3 years
Specificity (%) of biomarkers (PTX3 and VEGF)
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Measured: upon study completion, 3 years
Positive predictive value (%) of biomarkers (PTX3 and VEGF)
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Measured: upon study completion, 3 years
Negative predictive value (%) of biomarkers (PTX3 and VEGF)
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Measured: upon study completion, 3 years
Secondary outcomes (1)
Correlation of routine blood parameters with PTX 3 and VEGF.
Pearson's/Spearmann correlation routine blood parameters (ALT, AST, PLT count, HCT and WBC count) with the biomarkers to identify possible prognostic value.
Measured: upon study completion, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Gary Kim Kuan Low, Universiti Tunku Abdul Rahman
- Investigators
- Gary Low, Principal investigator, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606019
- Sponsor's protocol ID
- NMRR-15-1045-25937
- Status last verified
- Oct 2016
- First submitted
- 9 Nov 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Biomarkers in Predicting Dengue Outcome
- ClinicalTrials.gov ID
- NCT02606019
- Acronym / sponsor ID
- NMRR-15-1045-25937
- Conditions
- Dengue
- Keywords
- Pentraxin 3, Vascular Endothelial Growth Factor, dengue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 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 burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.
Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).
Detailed description
The burden of dengue infection has increased due to the current non-specific classification. A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1) and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in differentiating severe dengue from non-severe dengue cases. The analysis between severe dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at the margin of the pre-determined p-value of less than 0.05.
Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and liver function test (alanine aminotransferase and aspartate).
This is a prospective cohort study in which the patient will be followed up from the day of presentation to the attending practitioner until the patient is discharged. The blood samples will be obtained daily during the follow-up. The demography and clinical final diagnosis will be obtained from the medical record of the patient.
This study will aid triaging of dengue cases thereby reducing the need of unnecessary admission and better focused management to those might develop complication of dengue infection. This in turn reduces the workload and cost of the treating the dengue infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients will be recruited from primary care and followed up in the hospital if they were admitted.
Key inclusion criteria (4 listed)
- Participants who are age 15 or more.
- Participants must be recruited within the first three days of fever.
- Positive dengue by NS1Ag. Confirmed later on by paired dengue IgM/IgG.
- Final diagnosis of severe dengue or non-severe dengue.
Key exclusion criteria (4 listed)
- Participants who are less than 15 years old.
- Pregnant mothers.
- Participants should not have autoimmune disorder, haematological disorder, cancer, cardiovascular disease, on long term warfarin and aspirin.
- Participants who have been previously treated with dengue infection (secondary dengue infection will be excluded by dengue IgM/IgG).
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
Sensitivity (%) of biomarkers (PTX3 and VEGF)
Time frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Specificity (%) of biomarkers (PTX3 and VEGF)
Time frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Positive predictive value (%) of biomarkers (PTX3 and VEGF)
Time frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
Negative predictive value (%) of biomarkers (PTX3 and VEGF)
Time frame: upon study completion, 3 years
The measures will be analysed using Receiver Operating Characteristics (ROC) during the first 4 days of illness to predict the outcome of dengue infection (severe dengue versus non-severe dengue. Both univariate and multivariate analysis will be performed to identify and control for confounding factors.
1 secondary outcome
Correlation of routine blood parameters with PTX 3 and VEGF.
Time frame: upon study completion, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Related trials for Dengue
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
RecruitingObservational study
Immune Responses to Dengue and Sepsis
Dengue, Sepsis
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.
Gary Low principal investigator
Universiti Tunku Abdul Rahman
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Universiti Tunku Abdul Rahman at 2 sites in Malaysia.
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 4 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. 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 Gary Low, MPH (+60123150115, garylowkk@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (%) of biomarkers (PTX3 and VEGF) (time frame: upon study completion, 3 years). The study lists 4 primary outcomes in all. 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 25 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.