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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

Tracking Information
First Submitted Date  ICMJE August 15, 2019
First Posted Date  ICMJE August 21, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE December 27, 2016
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Sensitivity of dengue calculator [ Time Frame: 0 days ]
    Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dengue
Intervention  ICMJE Diagnostic Test: Dengue calculator
Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device
Study Arms  ICMJE 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)
Intervention: Diagnostic Test: Dengue calculator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2019)
1045
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fever of less than 15 days

Exclusion Criteria:

  • Origin of fever identified
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04063774
Other Study ID Numbers  ICMJE 144-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient unidentifiable data and detailed algorithms available upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Upon request for 10 years
Responsible Party Lyda Osorio, Universidad del Valle, Colombia
Study Sponsor  ICMJE Lyda Osorio
Collaborators  ICMJE
  • COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA
  • SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA
  • RED AEDES
Investigators  ICMJE
Principal Investigator: Lyda Osorio, MD PhD Universidad del Valle
Principal Investigator: Diana Ma Caicedo, MD MSc Universidad del Valle
PRS Account Universidad del Valle, Colombia
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP