Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa

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.

Study Overview

• Status: Completed
• Conditions: Malaria; Dengue; Chikungunya
• Intervention / Treatment: Diagnostic test: VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG; Other: Standard of care practices

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 Type: Interventional
• Enrollment (Actual): 804
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Ouagadougou, Burkina Faso
    • Institut de Recherche en Sciences de la Santé
• Côte D'Ivoire
  • Cocody
    • Abidjan, Cocody, Côte D'Ivoire
      • CHU Cocody
  • Treichville
    • Abidjan, Treichville, Côte D'Ivoire
      • CHU Treichville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Site; 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.	Diagnostic test: VIDAS® 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.
Placebo Comparator: Control Site; In the control centres, only routine practices were observed.	Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of antibiotic prescription	Rate of antibiotic prescription (discontinuation or non-initiation).	Inclusion and Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of hospital resources	Number of days in hospital.	Day 7
Consumption of hospital resources	Number of hospital visits within 7 days.	Day 7
Patient satisfaction	Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)).	Inclusion and Day 7
Patient's quality of life	Percentage on patient's quality of life (1 (worse) to 100 (better)) + EQ-5D questionnaire.	Inclusion and Day 7
Patient's loss of productivity	Questionnaire on number of working day lost.	Inclusion and Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of dengue, chikungunya and malaria	To determine the prevalence of dengue, chikungunya and malaria in patients with fever (≥38.5°C) of undetermined etiology	Inclusion, after lab results (an average of one day)
Clinical situations associated with inappropriate antibiotic prescription	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	Inclusion and Day 7
Rate of antibiotic prescription	To estimate the impact of differential diagnosis testing on the rate of antibiotic prescription in patients with dengue and/or chikungunya	Up to 7 days

Collaborators and Investigators

• Sponsor: BioMérieux

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Malaria; Diagnosis; Antibiotic; Dengue; West Africa; Antibiotic resistance; Chikungunya; Clinical Management; Patient Management; Immunoassays; Arboviruses
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Protozoan Infections; Parasitic Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections; Malaria; Dengue; Chikungunya Fever
• Other Study ID Numbers: E0545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No