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

Malaria Clinical Trial

Official title:

Impact of Differential and Systematic Dengue, Chikungunya, and Malaria Diagnostics on Patient Management and Antibiotic Use in Burkina Faso and Ivory Coast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06257810
• Other study ID #: E0545
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: October 24, 2023

Study information

• Verified date: February 2024
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: October 24, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chikungunya
• Chikungunya Fever
• Dengue
• Malaria

Intervention

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.

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.

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Sciences de la Santé	Ouagadougou
Côte D'Ivoire	CHU Cocody	Abidjan	Cocody
Côte D'Ivoire	CHU Treichville	Abidjan	Treichville

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Countries where clinical trial is conducted

Burkina Faso,  Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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
Primary	Rate of antibiotic prescription	Rate of antibiotic prescription (discontinuation or non-initiation).	Inclusion and Day 7
Secondary	Consumption of hospital resources	Number of days in hospital.	Day 7
Secondary	Consumption of hospital resources	Number of hospital visits within 7 days.	Day 7
Secondary	Patient satisfaction	Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)).	Inclusion and Day 7
Secondary	Patient's quality of life	Percentage on patient's quality of life (1 (worse) to 100 (better)) + EQ-5D questionnaire.	Inclusion and Day 7
Secondary	Patient's loss of productivity	Questionnaire on number of working day lost.	Inclusion and Day 7