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

NCT04063774 | Completed

• 1 other identifier: 144-016
• Study Type: interventional
• Target: 1,045
• Locations: 1 country
• Sites: 3

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

Keywords

diagnostics; sensitivity; specificity; clinical algorithm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Sensitivity in dengue and probable dengue cases

  0 days

Study Arms (1)

Dengue diagnostic algorithm

EXPERIMENTAL

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

Interventions

Dengue calculator DIAGNOSTIC_TEST

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

Dengue diagnostic algorithm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fever of less than 15 days

You may not qualify if:

• Origin of fever identified

Sponsors & Collaborators

• Lyda Osorio: lead
• COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA: collaborator
• SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA: collaborator
• RED AEDES: collaborator

Study Sites (3)

Hospital Regional de la Orinoquía

Yopal, Casanare Department, Colombia

Location

Clinica y Hospital Local de Piedecuesta

Piedecuesta, Santander Department, Colombia

Location

COMFANDI Torres y Alameda

Cali, Valle del Cauca Department, 760045, Colombia

Location

MeSH Terms

Conditions

Dengue; Hypersensitivity

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Immune System Diseases

Study Officials

• Lyda Osorio, MD PhD

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

• Diana Ma Caicedo, MD MSc

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Samples were coded and laboratory personnel were unaware of algorithm results, the participant did not know what algorithm prototype was tested.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Algorithms were developed and validated in silico, those with the highest sensitivity were tested in consecutive eligible subjects and their performance compared to dengue reference tests (gold standard combination of tests). Algorithms were modified according to intermediate analysis of performance planned in advance

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 21, 2019
• Study Start: December 27, 2016
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request for 10 years

Locations

CO (3)