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

Dengue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063774
• Other study ID #: 144-016
• Status: Completed
• Phase: N/A
• Start date: December 27, 2016
• Est. completion date: July 15, 2018

Study information

• Verified date: August 2019
• Source: Universidad del Valle, Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1045
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Fever of less than 15 days

Exclusion Criteria:

• Origin of fever identified

Related Conditions & MeSH terms

• Dengue

Intervention

Diagnostic Test:
• Dengue calculator
Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device

Locations

Country	Name	City	State
Colombia	COMFANDI Torres y Alameda	Cali	Valle Del Cauca
Colombia	Clinica y Hospital Local de Piedecuesta	Piedecuesta	Santander
Colombia	Hospital Regional de la Orinoquía	Yopal	Casanare

Sponsors (4)

Lead Sponsor	Collaborator
Lyda Osorio	COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA, RED AEDES, SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of dengue calculator	Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases	0 days
Primary	Specificity of dengue calculator	Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases	0 days
Secondary	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