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

Not Applicable

Completed

• Conditions: Dengue
• Interventions: Diagnostic Test: Dengue calculator

• Registration Number: NCT04063774
• Lead Sponsor: Lyda Osorio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Primary Completion: 2018-07-15
• Study Completion: 2018-07-15
• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 1045

Inclusion Criteria

• Fever of less than 15 days

Exclusion Criteria

• Origin of fever identified

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dengue diagnostic algorithm	Dengue calculator	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)

Primary Outcome Measures

Name	Time	Method
Sensitivity of dengue calculator	0 days	Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases
Specificity of dengue calculator	0 days	Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases

Secondary Outcome Measures

Name	Time	Method
Sensitivity in dengue and probable dengue cases	0 days	Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases

Trial Locations

Locations (3)

Hospital Regional de la Orinoquía; 🇨🇴 Yopal, Casanare, Colombia

COMFANDI Torres y Alameda; 🇨🇴 Cali, Valle Del Cauca, Colombia

Clinica y Hospital Local de Piedecuesta; 🇨🇴 Piedecuesta, Santander, Colombia