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

• ClinicalTrials.gov Identifier: NCT04063774
• Recruitment Status: Completed
• First Posted: August 21, 2019
• Last Update Posted: August 21, 2019
• Sponsor: Lyda Osorio
• 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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1045 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Lyda Osorio, MD PhD; Universidad del Valle
• Principal Investigator: Diana Ma Caicedo, MD MSc; Universidad del Valle

More Information

• Responsible Party: Lyda Osorio, Professor, Universidad del Valle, Colombia
• ClinicalTrials.gov Identifier: NCT04063774
• Other Study ID Numbers: 144-016
• First Posted: August 21, 2019
• 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

• 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:

Dengue; Arbovirus Infections; Vector Borne Diseases; Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral