An interventional study of Dengue calculator in Dengue, sponsored by Lyda Osorio. Completed at 3 sites in Colombia. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by Lyda Osorio · Not applicable, Interventional, and Diagnostic
The present study aimed to develop a sensitive dengue diagnostic clinical algorithm using the resources that are available at the health care institutions, clinical expertise, and identification of signs and symptoms and variables of the hemogram associated with dengue. The performance of the potential algorithms were assessed under routine care. A single group cuasiexperimental study with a Bayesian adaptive design was conducted. Prior and cumulative information was used during intermediate analysis of clinical algorithms performance and according to these results algorithms were modified and then implemented in the subsequent study subjects. Men and women of all ages, seeking care due to fever of less than 15 days were recruited in 3 endemic areas in Colombia. The algorithms were applied by study physicians and blood samples taken for hemogram and dengue reference tests. It was planned that algorithms with high sensitivity (95%) and specificity (80%) were implemented in real life to assess their impact on patients outcomes alone and in combination with dengue rapid diagnostic tests but this was not feasible as not algorithms achieved the targetted performance. The experience of physicians using the algorithm in a mobile device was going to be explored with qualitative methods but this was explored with study physicians.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 1,045 is above the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →This is the only study on the registry with Lyda Osorio as lead sponsor.
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Exclusion Criteria:
single arm of consecutive enrolled subjects with fever in whom the dengue diagnostic algorithms were applied by study physician and blood sample taken for hemogram and dengue reference tests (gold standard)
Diagnostic Test: Dengue calculator
Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device
Sensitivity of dengue calculator
Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases
Time frame: 0 days
Specificity of dengue calculator
Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases
Time frame: 0 days
Sensitivity in dengue and probable dengue cases
Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases
Time frame: 0 days
Plan to share: Yes — Patient unidentifiable data and detailed algorithms available upon request
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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