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

Not Applicable

Completed

• Conditions: Dengue; Malaria; Chikungunya
• Interventions: 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

• Registration Number: NCT06257810
• Lead Sponsor: BioMérieux

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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-06-07
• Study Completion: 2023-10-24
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Site	VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG	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.
Control Site	Standard of care practices	In the control centres, only routine practices were observed.

Primary Outcome Measures

Name	Time	Method
Rate of antibiotic prescription	Inclusion and Day 7	Rate of antibiotic prescription (discontinuation or non-initiation).

Secondary Outcome Measures

Name	Time	Method
Patient's loss of productivity	Inclusion and Day 7	Questionnaire on number of working day lost.
Consumption of hospital resources	Day 7	Number of hospital visits within 7 days.
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 satisfaction	Inclusion and Day 7	Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)).

Trial Locations

Locations (3)

CHU Cocody; 🇨🇮 Abidjan, Cocody, Côte D'Ivoire

CHU Treichville; 🇨🇮 Abidjan, Treichville, Côte D'Ivoire

Institut de Recherche en Sciences de la Santé; 🇧🇫 Ouagadougou, Burkina Faso