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

NCT ID: NCT04063774

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1045 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2018-07-15

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.

Conditions

Dengue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Dengue calculator

Intervention Type: DIAGNOSTIC_TEST

Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device

Interventions

Dengue calculator

Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Fever of less than 15 days

Exclusion Criteria

• Origin of fever identified

• Accepts Healthy Volunteers: No

Sponsors

COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA

UNKNOWN

Sponsor Role: collaborator

SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA

UNKNOWN

Sponsor Role: collaborator

RED AEDES

UNKNOWN

Sponsor Role: collaborator

Lyda Osorio

OTHER

Sponsor Role: lead

Responsible Party

Lyda Osorio

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lyda Osorio, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad del Valle

Diana Ma Caicedo, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad del Valle

Locations

Hospital Regional de la Orinoquía

Yopal, Casanare Department, Colombia

Clinica y Hospital Local de Piedecuesta

Piedecuesta, Santander Department, Colombia

COMFANDI Torres y Alameda

Cali, Valle del Cauca Department, Colombia

Countries

Colombia

Other Identifiers

144-016

Identifier Type: -

Identifier Source: org_study_id