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

NCT04063774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1045

Last updated 2019-08-21

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Dengue calculator

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

Sponsors & Collaborators

  • COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA

    collaborator UNKNOWN

  • SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA

    collaborator UNKNOWN

  • RED AEDES

    collaborator UNKNOWN

  • Lyda Osorio

    lead OTHER

Principal Investigators

  • Lyda Osorio, MD PhD · Universidad del Valle

  • Diana Ma Caicedo, MD MSc · Universidad del Valle

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-27
Primary Completion
2018-07-15
Completion
2018-07-15

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063774 on ClinicalTrials.gov