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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 November 2016
Main ID:  NCT02606019
Date of registration: 09/11/2015
Prospective Registration: No
Primary sponsor: Universiti Tunku Abdul Rahman
Public title: The Use of Biomarkers in Predicting Dengue Outcome
Scientific title: The Use of Biomarkers in Predicting Dengue Outcome
Date of first enrolment: October 2015
Target sample size: 108
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02606019
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Malaysia
Contacts
Name:     Gary Low, MPH
Address: 
Telephone: +60123150115
Email: garylowkk@utar.edu.my
Affiliation: 
Name:     Gary Low
Address: 
Telephone:
Email:
Affiliation:  Universiti Tunku Abdul Rahman
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).



Age minimum: 15 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Dengue
Intervention(s)
Primary Outcome(s)
Negative predictive value (%) of biomarkers (PTX3 and VEGF) [Time Frame: upon study completion, 3 years]
Positive predictive value (%) of biomarkers (PTX3 and VEGF) [Time Frame: upon study completion, 3 years]
Sensitivity (%) of biomarkers (PTX3 and VEGF) [Time Frame: upon study completion, 3 years]
Specificity (%) of biomarkers (PTX3 and VEGF) [Time Frame: upon study completion, 3 years]
Secondary Outcome(s)
Correlation of routine blood parameters with PTX 3 and VEGF. [Time Frame: upon study completion, 3 years]
Secondary ID(s)
NMRR-15-1045-25937
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, Malaysia
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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