DengueNCT04063774
Clinical Trial of Diagnostic Tests and Clinical Algorithms for Dengue in Febrile Subjects in Endemic Areas in Colombia
A study testing Dengue calculator in people with Dengue, run by Lyda Osorio at 3 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dengue
- What is being tested?
- Dengue calculator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 3 sitesColombia
- Study dates
- 27 Dec 2016to 15 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fever of less than 15 days
Who cannot join
- Origin of fever identified
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
COMFANDI Torres y Alameda
Cali, Valle del Cauca Department, 760045
Clinica y Hospital Local de Piedecuesta
Piedecuesta, Santander Department
Hospital Regional de la Orinoquía
Yopal, Casanare Department
About this study
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
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
- Being tested
- Dengue calculator
- Keywords
- diagnostics, sensitivity, specificity, clinical algorithm
- Medical subject headings
- Dengue, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue calculatorDiagnostic test
Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Dengue calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of dengue calculator
Number of correctly identified dengue cases by intervention out of all laboratory confirmed dengue cases
Measured: 0 days
Specificity of dengue calculator
Number of correctly identified non-dengue cases by intervention out of all laboratory confirmed non-dengue cases
Measured: 0 days
Secondary outcomes (1)
Sensitivity in dengue and probable dengue cases
Number of correctly identified dengue cases by intervention out of all laboratory confirmed plus probable dengue cases
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start27 Dec 2016
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyda Osorio
- Sponsor type
- University, hospital or other
- Collaborators
- COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA, SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA, RED AEDES
- Responsible party
- Sponsor-investigator, Lyda Osorio, Universidad del Valle, Colombia
- Investigators
- Lyda Osorio, MD PhD, Principal investigator, Universidad del ValleDiana Ma Caicedo, MD MSc, Principal investigator, Universidad del Valle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063774
- Sponsor's protocol ID
- 144-016
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient unidentifiable data and detailed algorithms available upon request
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04063774
- Acronym / sponsor ID
- 144-016
- Conditions
- Dengue
- Keywords
- diagnostics, sensitivity, specificity, clinical algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- Lyda OsorioUniversity, hospital or other
- Collaborators
- COMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA, SISTEMA GENERAL DE REGALIAS CASANARE, SANTANDER VALLE DEL CAUCA, RED AEDES
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Dengue diagnostic algorithm | Experimental | Diagnostic Test: Dengue calculatorsingle 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) |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fever of less than 15 days
Key exclusion criteria (1 listed)
- Origin of fever identified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengue calculatorClinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device | Diagnostic test | Dengue diagnostic algorithm |
Primary outcome
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
1 secondary outcome
Sensitivity in dengue and probable dengue cases
Time frame: 0 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Yes. Patient unidentifiable data and detailed algorithms available upon request
Related trials for Dengue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyda Osorio, MD PhD principal investigator
Universidad del Valle
Diana Ma Caicedo, MD MSc principal investigator
Universidad del Valle
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dengue calculator in people with Dengue, run by Lyda Osorio at 3 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of dengue calculator (time frame: 0 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.