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

bioMérieux

Status: Completed

Conditions: Dengue; Chikungunya; Malaria

Treatments: 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06257810

E0545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 804 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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804 participants in 2 patient groups, including a placebo group

Intervention Site

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

In the control centres, only routine practices were observed.

Treatment:

Other: Standard of care practices