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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02059122 |
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Date of registration:
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07/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sensitivity Study of Diagnostic for Early Detection of Dengue Infection
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Scientific title:
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Determination of Estimated Sensitivity for Dengue NS1 ELISAs |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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911 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02059122 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Barbados
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Colombia
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Sri Lanka
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Thailand
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All age groups and both sexes.
- Initial serum samples must be collected within 1- 7 days of onset of symptoms
consistent with Dengue virus infection.
- Information must be available about symptoms, age, and sex of patient from which
samples are collected.
- The location of sample collection must be recorded.
- Archived samples that have been sent to reference labs for dengue or flavivirus
testing should be considered for inclusion as test specimens in this study. If these
specimens are included in this study, then they must have a documented history that
the specimen was obtained within the first 7 days of onset of subject symptoms
consistent with dengue infection.
Exclusion Criteria:
- Archived samples with linked personal identifiers or any sample for which personal
information can be discovered.
- Prospective samples from nursing home residents; inmates/subjects in police custody;
participants who are unable to understand verbal or written local language in which a
certified translation of the informed consent is available, or requires a Legal
Authorized Representative (LAR) for consent.
- Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that
have not been stored frozen.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infectious Diseases
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Primary Outcome(s)
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number of subjects with positive result
[Time Frame: 1 day]
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Secondary ID(s)
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DSC0202/0093
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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