Clinical trial NCT06257810: Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa
Official title: Impact of Differential and Systematic Dengue, Chikungunya, and Malaria Diagnostics on Patient Management and Antibiotic Use in Burkina Faso and Ivory Coast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Chikungunya
Malaria
Keywords: Diagnosis
Clinical Management
Antibiotic
Patient Management
Immunoassays
Arboviruses
West Africa
Antibiotic resistance
Dengue
Malaria
Chikungunya
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of antibiotic prescription
timeFrame: Inclusion and Day 7
Secondary outcomes:
measure: Consumption of hospital resources
timeFrame: Day 7
measure: Consumption of hospital resources
timeFrame: Day 7
measure: Patient satisfaction
timeFrame: Inclusion and Day 7
measure: Patient's quality of life
timeFrame: Inclusion and Day 7
measure: Patient's loss of productivity
timeFrame: Inclusion and Day 7
Other outcomes:
measure: Prevalence of dengue, chikungunya and malaria
timeFrame: Inclusion, after lab results (an average of one day)
measure: Clinical situations associated with inappropriate antibiotic prescription
timeFrame: Inclusion and Day 7
measure: Rate of antibiotic prescription
timeFrame: Up to 7 days
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé
city: Abidjan
country: Côte D'Ivoire
facility: CHU Cocody
state: Cocody
city: Abidjan
country: Côte D'Ivoire
facility: CHU Treichville
state: Treichville
Study officials:
References: