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
NCT number | NCT06257810 |
Other study ID # | E0545 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 1, 2023 |
Est. completion date | October 24, 2023 |
Verified date | February 2024 |
Source | BioMérieux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
BioMérieux |
Burkina Faso, Côte D'Ivoire,
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 |
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