Patients with suspected infection or suspected inflammatory conditions including patients with suspected COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A patient of any age who attends or who is admitted at a participating hospital 2. AND who has one or more of the following; 2.1. Fever (=38.0 °C) or history of fever in the preceding 24 hours 2.2. Symptoms (including non-specific signs) suggestive of infection 2.3. Symptoms suggestive of inflammation (including exacerbation of pre-existing inflammatory disease), and including non-specific signs/symptoms such as fever, joint pains, muscle pains, headaches, lymphadenopathy/fatigue, abdominal pain, rashes, mucosal inflammation, elevated inflammatory markers, unexplained cytopenias 3. AND EITHER who gives consent for samples to be taken for research 4. OR who retrospectively gives consent, according to a deferred consent model in which consent is obtained after initial sample collection
Exclusion criteria
Exclusion criteria: 1. Patients who do not give consent 2. RNA sample is not taken
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene expression measured using RNA sequencing at presentation in children and adults with different infectious and inflammatory conditions RNA biomarker signature with a sensitivity of 95% and specificity of 95% based on groups of at least 50 patients in each diagnostic category, which would allow capture of the effect sizes between the different comparator groups of as little as 1.5 fold change. | — |
Secondary
| Measure | Time frame |
|---|---|
| Healthcare resource use of patients presenting with infectious and inflammatory illness measured using qualitative questionnaire during admission and 3-6 months after admission | — |
Countries
Austria, England, France, Gambia, Germany, Greece, Italy, Latvia, Nepal, Netherlands, Slovenia, Spain, Switzerland, Taiwan, United Kingdom