Diagnosis of malarial, viral and bacterial infections among children with fever Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The participant is between the ages of 1 month and 15 years 2. Participant has a reported fever or recorded fever of =37.5°C in the past 24 hours and is suspected by a clinician to have an infection 3. Parental permission and child assent have been obtained
Exclusion criteria
Exclusion criteria: 1. Children aged 16 years or older 2. Children without recorded/reported fever. 3. Inability to provide informed consent. 4. Children with fever from a suspected hospital-acquired infection 5. Children suspected by clinicians to have a high-consequence infectious disease such as viral haemorrhagic fever 6. Children with known HIV or other immunodeficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy will be measured using the area under the receiver operator curve (AUC) for the results of the Lacewing device compared against reference standard (blood film microscopy, sterile site culture, and molecular pathogen detection), assessed at the time of clinical presentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The prevalence of different types of infection classified by gene expression test will be assessed for samples collected at time of clinical presentation 2. The usability of the test will be evaluated through stakeholder engagements on the day that the primary outcome is measured | — |
Countries
Ghana