DengueNCT06257810
Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa
A study testing VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG in people with Dengue and Chikungunya, run by BioMérieux at 3 sites in 2 countries.
Trial summary
The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue, Chikungunya, Malaria
- What is being tested?
- VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 804 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2023to 24 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥ 18 years
- Patient with fever (≥38.5°C) and at least two of the following symptoms in the last 10 days:
- Severe headache
- Retro-orbital pain
- Muscle and joint pain
- Nausea
Show all 15Show fewer
- Vomiting
- Adenopathy
- Rash
- Abdominal pain
- Asthenia
- Spontaneous bleeding (purpura, epistaxis, haematemesis, etc)
- Willingness and ability to provide two 4 mL blood samples
- Willingness to provide one drop of blood per capillary sample
- Informed and signed consent
Who cannot join
- Subjects aged < 18 years
- Pregnant women
- Breastfeeding women
- Patient's refusal to participate in the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Côte d’Ivoire2 sites
CHU Cocody
Abidjan, Cocody
CHU Treichville
Abidjan, Treichville
Burkina Faso1 site
Institut de Recherche en Sciences de la Santé
Ouagadougou
About this study
Official title: Impact of Differential and Systematic Dengue, Chikungunya, and Malaria Diagnostics on Patient Management and Antibiotic Use in Burkina Faso and Ivory Coast
The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.
Read the detailed description
The research hypotheses are as follows:
- Systematic diagnosis of malaria, dengue and chikungunya using diagnostic tests would improve the clinical management of patients with fever of undetermined etiology and reduce the misuse of antibiotics (discontinuation or non-initiation) and associated resistance.
- Improved management is associated with a reduction in the use of hospital resources, professional inactivity and an improvement in the quality of life and satisfaction of patients.
- Conditions
- Dengue, Chikungunya, Malaria
- Being tested
- VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG, Standard of care practices
- Keywords
- Diagnosis, Clinical Management, Antibiotic, Patient Management, Immunoassays, Arboviruses, West Africa, Antibiotic resistance, Dengue, Malaria, Chikungunya
- Medical subject headings
- Dengue, Chikungunya Fever, Malaria, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgGDiagnostic test
For patients managed in an "intervention site", a diagnostic test for dengue and chikungunya using VIDAS® as well as a screening test for malaria will be carried out. An awareness campaign on the use of VIDAS® diagnostic tests will be implemented as well.
The diagnosis will be based on the patient's clinical symptoms, the biological results of the VIDAS® tests for dengue and chikungunya, as well as the results of the tests for malaria.
Standard of care practicesOther
For patients managed in a "control site", the standard of care practices will be applied in the case of a febrile condition of undetermined etiology. This includes clinical diagnosis and, where appropriate, the use of routinely available diagnostic tests. At the end of the study, the collected samples will be tested using VIDAS® differential diagnosis tests to estimate the number of cases of dengue and chikungunya that have not been correctly diagnosed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site | Active comparator | In the interventional sites, bioMérieux teams provided training to raise awareness of the diagnosis of dengue, chikungunya and malaria. In addition, a VIDAS instrument was installed and dengue and chikungunya diagnostic kits were supplied so that diagnosis could be carried out systematically for each patient included. Receives: Diagnostic Test: VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG |
| Control Site | Placebo comparator | In the control centres, only routine practices were observed. Receives: Other: Standard of care practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of antibiotic prescription
Rate of antibiotic prescription (discontinuation or non-initiation).
Measured: Inclusion and Day 7
Secondary outcomes (5)
Consumption of hospital resources
Number of days in hospital.
Measured: Day 7
Consumption of hospital resources
Number of hospital visits within 7 days.
Measured: Day 7
Patient satisfaction
Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)).
Measured: Inclusion and Day 7
Patient's quality of life
Percentage on patient's quality of life (1 (worse) to 100 (better)) + EQ-5D questionnaire.
Measured: Inclusion and Day 7
Patient's loss of productivity
Questionnaire on number of working day lost.
Measured: Inclusion and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jun 2023
- Primary completion7 Jun 2023
- Study completion24 Oct 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentric study which will be carried out in four hospitals, two in Burkina Faso and two in Ivory Coast. In each of these two countries, an "intervention" site and a "control" site will be included in the study. The study is interventional as the investigators collected additional blood samples than the routine practices.
- Masking
- None (open label)
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257810
- Sponsor's protocol ID
- E0545
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2023
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Differential and Systematic Dengue, Chikungunya, and Malaria Diagnostics on Patient Management and Antibiotic Use in Burkina Faso and Ivory Coast
- ClinicalTrials.gov ID
- NCT06257810
- Acronym / sponsor ID
- E0545
- Conditions
- Dengue, Chikungunya, Malaria
- Keywords
- Diagnosis, Clinical Management, Antibiotic, Patient Management, Immunoassays, Arboviruses, West Africa, Antibiotic resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 14 Feb 2024 (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 differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.
Detailed description
The research hypotheses are as follows:
- Systematic diagnosis of malaria, dengue and chikungunya using diagnostic tests would improve the clinical management of patients with fever of undetermined etiology and reduce the misuse of antibiotics (discontinuation or non-initiation) and associated resistance.
- Improved management is associated with a reduction in the use of hospital resources, professional inactivity and an improvement in the quality of life and satisfaction of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicentric study which will be carried out in four hospitals, two in Burkina Faso and two in Ivory Coast. In each of these two countries, an "intervention" site and a "control" site will be included in the study. The study is interventional as the investigators collected additional blood samples than the routine practices.
| Arm | Type | Receives |
|---|---|---|
| Intervention Site | Active comparator | Diagnostic Test: VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgGIn the interventional sites, bioMérieux teams provided training to raise awareness of the diagnosis of dengue, chikungunya and malaria. In addition, a VIDAS instrument was installed and dengue and chikungunya diagnostic kits were supplied so that diagnosis could be carried out systematically for each patient included. |
| Control Site | Placebo comparator | Other: Standard of care practicesIn the control centres, only routine practices were observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects aged ≥ 18 years
- Patient with fever (≥38.5°C) and at least two of the following symptoms in the last 10 days:
- Willingness and ability to provide two 4 mL blood samples
- Willingness to provide one drop of blood per capillary sample
- Informed and signed consent
Key exclusion criteria (4 listed)
- Subjects aged < 18 years
- Pregnant women
- Breastfeeding women
- Patient's refusal to participate in the study
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 |
|---|---|---|
| VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgGFor patients managed in an "intervention site", a diagnostic test for dengue and chikungunya using VIDAS® as well as a screening test for malaria will be carried out. An awareness campaign on the use of VIDAS® diagnostic tests will be implemented as well. The diagnosis will be based on the patient's clinical symptoms, the biological results of the VIDAS® tests for dengue and chikungunya, as well as the results of the tests for malaria. | Diagnostic test | Intervention Site |
| Standard of care practicesFor patients managed in a "control site", the standard of care practices will be applied in the case of a febrile condition of undetermined etiology. This includes clinical diagnosis and, where appropriate, the use of routinely available diagnostic tests. At the end of the study, the collected samples will be tested using VIDAS® differential diagnosis tests to estimate the number of cases of dengue and chikungunya that have not been correctly diagnosed. | Other | Control Site |
Primary outcome
Rate of antibiotic prescription
Time frame: Inclusion and Day 7
Rate of antibiotic prescription (discontinuation or non-initiation).
5 secondary outcomes
Consumption of hospital resources
Time frame: Day 7
Consumption of hospital resources
Time frame: Day 7
Patient satisfaction
Time frame: Inclusion and Day 7
Patient's quality of life
Time frame: Inclusion and Day 7
Patient's loss of productivity
Time frame: Inclusion and Day 7
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 11 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG in people with Dengue and Chikungunya, run by BioMérieux at 3 sites in 2 countries.
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 15 inclusion and 4 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 11 Feb 2025. 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 Côte d’Ivoire, 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. Some participants in this study may receive a placebo. 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?
Rate of antibiotic prescription (time frame: Inclusion and Day 7). 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 11 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.