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

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ClinicalTrials.gov Identifier: NCT04063774
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA
SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA
RED AEDES
Information provided by (Responsible Party):
Lyda Osorio, Universidad del Valle, Colombia

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.

Condition or disease Intervention/treatment Phase
Dengue Diagnostic Test: Dengue calculator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1045 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Masking Description: Samples were coded and laboratory personnel were unaware of algorithm results, the participant did not know what algorithm prototype was tested.
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

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




Primary Outcome Measures :
  1. Sensitivity of dengue calculator [ Time Frame: 0 days ]
    Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases

  2. Specificity of dengue calculator [ Time Frame: 0 days ]
    Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases


Secondary Outcome Measures :
  1. Sensitivity in dengue and probable dengue cases [ Time Frame: 0 days ]
    Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fever of less than 15 days

Exclusion Criteria:

  • Origin of fever identified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063774


Locations
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Colombia
Hospital Regional de la Orinoquía
Yopal, Casanare, Colombia
Clinica y Hospital Local de Piedecuesta
Piedecuesta, Santander, Colombia
COMFANDI Torres y Alameda
Cali, Valle Del Cauca, Colombia, 760045
Sponsors and Collaborators
Lyda Osorio
COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA
SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA
RED AEDES
Investigators
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Principal Investigator: Lyda Osorio, MD PhD Universidad del Valle
Principal Investigator: Diana Ma Caicedo, MD MSc Universidad del Valle

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Responsible Party: Lyda Osorio, Professor, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT04063774     History of Changes
Other Study ID Numbers: 144-016
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient unidentifiable data and detailed algorithms available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Upon request for 10 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lyda Osorio, Universidad del Valle, Colombia:
diagnostics
sensitivity
specificity
clinical algorithm
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral