DengueNCT04582474
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
A study testing Dengue module and rapid diagnostic tests in people with Dengue, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in Burkina Faso.
Trial summary
The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Dengue
- What is being tested?
- Dengue module and rapid diagnostic tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 2 sitesBurkina Faso
- Study dates
- 10 Sep 2020to 31 Dec 2020
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older than 6 month
- Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
- Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure
Who cannot join
- Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
- Patients with severe disease requiring urgent care
Trial locations and contacts
2 sites in 1 country.
Burkina Faso2 sites
Centre de Santé et de Promotion Sociale (Sandogo)
Ouagadougou, District Boulmiougou
Centre de Santé et de Promotion Sociale (Secteur 16)
Ouagadougou, District Boulmiougou
About this study
Official title: Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response.
The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive.
Read more
An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease.
In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.
- Conditions
- Dengue
- Being tested
- Dengue module and rapid diagnostic tests
- Keywords
- Non-malarial fevers, Clinical decision support tools, Rapid diagnostic test
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue module and rapid diagnostic testsOther
Digital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines
| Study group | Role | What they receive |
|---|---|---|
| Dengue module and rapid diagnostic tests | Experimental | Not described Receives: Other: Dengue module and rapid diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
This outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
Measured: 4 months
Evaluation of the adherence to the different steps of the module
This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
Measured: 4 months
Secondary outcomes (4)
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
Measured: 4 months
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.
Measured: 4 months
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
Measured: 4 months
Positive predictive value of dengue rapid diagnostic test
Polymerase chain reaction results will be used as the reference test.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start10 Sep 2020
- Primary completion20 Nov 2020
- Study completion31 Dec 2020
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
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Burkina Faso, Terre des hommes, Burkina Faso & Switzerland
- Responsible party
- Sponsor
- Investigators
- Brice W Bicaba, MD, Principal investigator, Ministry of Health, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582474
- Sponsor's protocol ID
- FE008
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
- ClinicalTrials.gov ID
- NCT04582474
- Acronym / sponsor ID
- FE008
- Conditions
- Dengue
- Keywords
- Non-malarial fevers, Clinical decision support tools, Rapid diagnostic test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Ministry of Health, Burkina Faso, Terre des hommes, Burkina Faso & Switzerland
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Oct 2020 (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 Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response.
The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive.
An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease.
In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dengue module and rapid diagnostic tests | Experimental | Other: Dengue module and rapid diagnostic tests |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 6 month
- Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
- Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure
Key exclusion criteria (2 listed)
- Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
- Patients with severe disease requiring urgent care
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 module and rapid diagnostic testsDigital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines | Other | Dengue module and rapid diagnostic tests |
Primary outcome
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
Time frame: 4 months
This outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
Evaluation of the adherence to the different steps of the module
Time frame: 4 months
This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
4 secondary outcomes
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
Time frame: 4 months
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.
Time frame: 4 months
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
Time frame: 4 months
Positive predictive value of dengue rapid diagnostic test
Time frame: 4 months
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 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Dengue
Active, not recruitingPhase 3
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Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
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Active, not recruiting
A Controlled Human Infection Model of Dengue
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Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
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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.
Brice W Bicaba, MD principal investigator
Ministry of Health, Burkina Faso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dengue module and rapid diagnostic tests in people with Dengue, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in Burkina Faso.
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 3 inclusion and 2 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso. 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?
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals (time frame: 4 months). 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 16 Sep 2026.