Clinical trial NCT04063774: Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Keywords: diagnostics
sensitivity
specificity
clinical algorithm
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
Collaborators: name: COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA
name: SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA
name: RED AEDES
First posted: 2019-08-21
Enrollment: 1045
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* Fever of less than 15 days

Exclusion Criteria:

* Origin of fever identified

Primary outcomes:
measure: Sensitivity of dengue calculator
timeFrame: 0 days
measure: Specificity of dengue calculator
timeFrame: 0 days
Secondary outcomes:
measure: Sensitivity in dengue and probable dengue cases
timeFrame: 0 days
Other outcomes:
Locations:
city: Yopal
country: Colombia
facility: Hospital Regional de la Orinoquía
state: Casanare
city: Piedecuesta
country: Colombia
facility: Clinica y Hospital Local de Piedecuesta
state: Santander
city: Cali
country: Colombia
facility: COMFANDI Torres y Alameda
state: Valle Del Cauca
Study officials:
affiliation: Universidad del Valle
name: Lyda Osorio, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Valle
name: Diana Ma Caicedo, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: