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

NCT ID: NCT06257810

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-10-24

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.

Conditions

Dengue; Chikungunya; Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Control Site

In the control centres, only routine practices were observed.

Group Type: PLACEBO_COMPARATOR

Standard of care practices

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMérieux

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de Recherche en Sciences de la Santé

Ouagadougou, , Burkina Faso

CHU Cocody

Abidjan, Cocody, Côte d’Ivoire

CHU Treichville

Abidjan, Treichville, Côte d’Ivoire

Countries

Burkina Faso; Côte d’Ivoire

Other Identifiers

E0545

Identifier Type: -

Identifier Source: org_study_id