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

NCT06257810 | Completed

• 1 other identifier: E0545
• Study Type: interventional
• Target: 804
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dengue; Chikungunya; Malaria

Keywords

Diagnosis; Clinical Management; Antibiotic; Patient Management; Immunoassays; Arboviruses; West Africa; Antibiotic resistance; Dengue; Malaria; Chikungunya

Outcome Measures

Primary Outcomes (1)

• Rate of antibiotic prescription

  Rate of antibiotic prescription (discontinuation or non-initiation).

  Inclusion and Day 7

Secondary Outcomes (5)

• Consumption of hospital resources

  Day 7

• Consumption of hospital resources

  Day 7

• Patient satisfaction

  Inclusion and Day 7

• Patient's quality of life

  Inclusion and Day 7

• Patient's loss of productivity

  Inclusion and Day 7

Other Outcomes (3)

• Prevalence of dengue, chikungunya and malaria

  Inclusion, after lab results (an average of one day)

• Clinical situations associated with inappropriate antibiotic prescription

  Inclusion and Day 7

• Rate of antibiotic prescription

  Up to 7 days

Study Arms (2)

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.

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.

Other: Standard of care practices

Interventions

VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG DIAGNOSTIC_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.

Intervention Site

Standard of care practices OTHER

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.

Control Site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects aged \< 18 years
• Pregnant women
• Breastfeeding women
• Patient's refusal to participate in the study

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (3)

Institut de Recherche en Sciences de la Santé

Ouagadougou, Burkina Faso

Location

CHU Cocody

Abidjan, Cocody, Côte d’Ivoire

Location

CHU Treichville

Abidjan, Treichville, Côte d’Ivoire

Location

MeSH Terms

Conditions

Dengue; Chikungunya Fever; Malaria; Disease

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections; Protozoan Infections; Parasitic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 14, 2024
• Study Start: June 1, 2023
• Primary Completion: June 7, 2023
• Study Completion: October 24, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); CÔ (2)