Chikungunya, Dengue, Malaria
Conditions
Keywords
Diagnosis, Clinical Management, Antibiotic, Patient Management, Immunoassays, Arboviruses, West Africa, Antibiotic resistance, Dengue, Malaria, Chikungunya
Brief 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 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.
Interventions
DIAGNOSTIC_TESTVIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG
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.
OTHERStandard of care practices
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.
Sponsors
BioMérieux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* Subjects aged \< 18 years * Pregnant women * Breastfeeding women * Patient's refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of antibiotic prescription | Inclusion and Day 7 | Rate of antibiotic prescription (discontinuation or non-initiation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Inclusion and Day 7 | Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)). |
| Consumption of hospital resources | Day 7 | Number of days in hospital. |
| Patient's quality of life | Inclusion and Day 7 | Percentage on patient's quality of life (1 (worse) to 100 (better)) + EQ-5D questionnaire. |
| Patient's loss of productivity | Inclusion and Day 7 | Questionnaire on number of working day lost. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of antibiotic prescription | Up to 7 days | To estimate the impact of differential diagnosis testing on the rate of antibiotic prescription in patients with dengue and/or chikungunya |
| Clinical situations associated with inappropriate antibiotic prescription | Inclusion and Day 7 | Number of clinical situations associated with inappropriate antibiotic prescription, including suggestive signs of bacterial infection or severe sepsis such as neurological, cardio-circulatory failure, coma or purpura fulminans |
| Prevalence of dengue, chikungunya and malaria | Inclusion, after lab results (an average of one day) | To determine the prevalence of dengue, chikungunya and malaria in patients with fever (≥38.5°C) of undetermined etiology |
Countries
Burkina Faso, Côte d’Ivoire
Outcome results
None listed