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Completed

NCT Number: NCT06257810

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Rate of antibiotic prescription

    Time frame: Inclusion and Day 7

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

Secondary outcomes

  1. Consumption of hospital resources

    Time frame: Day 7

    Number of days in hospital.

  2. Consumption of hospital resources

    Time frame: Day 7

    Number of hospital visits within 7 days.

  3. Patient satisfaction

    Time frame: Inclusion and Day 7

    Patient satisfaction with the health care (measured on a scale of 1 (worse) to 5 (better)).

  4. Patient's quality of life

    Time frame: Inclusion and Day 7

    Percentage on patient's quality of life (1 (worse) to 100 (better)) + EQ-5D questionnaire.

  5. Patient's loss of productivity

    Time frame: Inclusion and Day 7

    Questionnaire on number of working day lost.

Other outcomes

  1. Prevalence of dengue, chikungunya and malaria

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

    To determine the prevalence of dengue, chikungunya and malaria in patients with fever (≥38.5°C) of undetermined etiology

  2. Clinical situations associated with inappropriate antibiotic prescription

    Time frame: Inclusion and Day 7

    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

  3. Rate of antibiotic prescription

    Time frame: Up to 7 days

    To estimate the impact of differential diagnosis testing on the rate of antibiotic prescription in patients with dengue and/or chikungunya

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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