An interventional study of Dengue module and rapid diagnostic tests in Dengue, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 2 sites in Burkina Faso. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Not applicable, Interventional, and Diagnostic
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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.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's enrollment of 335 is above the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Other: Dengue module and rapid diagnostic tests
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
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.
Time frame: 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.
Time frame: 4 months
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
Polymerase chain reaction results will be used as the reference test.
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Nov 2020, 2 months.
Of 25 non-industry interventional studies with no phase under Dengue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 2 months is below that.
Counting every sponsor, half of 30 studies reached it within 12 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland