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

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

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.

Study Overview

• Status: Completed
• Conditions: Dengue
• Intervention / Treatment: Diagnostic test: Dengue calculator

• Study Type: Interventional
• Enrollment (Actual): 1045
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Casanare
    • Yopal, Casanare, Colombia
      • Hospital Regional de la Orinoquía
  • Santander
    • Piedecuesta, Santander, Colombia
      • Clinica y Hospital Local de Piedecuesta
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760045
      • COMFANDI Torres y Alameda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fever of less than 15 days

Exclusion Criteria:

• Origin of fever identified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dengue diagnostic algorithm; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lyda Osorio
• Collaborators: COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA; SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA; RED AEDES
• Investigators: Principal Investigator: Lyda Osorio, MD PhD, Universidad del Valle; Principal Investigator: Diana Ma Caicedo, MD MSc, Universidad del Valle

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 27, 2016
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): July 15, 2018

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: sensitivity; specificity; diagnostics; clinical algorithm
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: 144-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient unidentifiable data and detailed algorithms available upon request
• IPD Sharing Time Frame: Upon request for 10 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No