Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Clinical Trial of the Validity and Impact of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia 2016

Conditions
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Dengue

Intervention / Treatment
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* Diagnostic Test: Dengue calculator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fever of less than 15 days Exclusion Criteria: Origin of fever identified

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Algorithms were developed and validated in silico, those with the highest sensitivity were tested in consecutive eligible subjects and their performance compared to dengue reference tests (gold standard combination of tests). Algorithms were modified according to intermediate analysis of performance planned in advance
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dengue diagnostic algorithm<br>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<br>* Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of dengue calculator | Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases | 0 days | 
| Specificity of dengue calculator | Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity in dengue and probable dengue cases | Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases | 0 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostics, sensitivity, specificity, clinical algorithm