Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis
Closed to recruitment
This study aims to bring a new Personalised Medicine (PM) approach to the diagnosis of infectious and inflammatory diseases, based on individual RNA signatures detected in blood. It will demonstrate the benefit of this approach to individuals and healthcare systems and its economic viability. We aim to develop a novel molecular taxonomy of infectious and inflammatory disease, which will be used as the basis for personalised diagnosis by identifying the specific “signature” of each disease using a novel approach, termed “Personalised Molecular Signature Diagnosis (PMSD)”. This approach uses each individual patient’s gene expression in blood to identify RNA signatures, which are specific to individual infectious or inflammatory diseases. In collaboration with biotechnology and industrial partners, we will develop novel devices to rapidly detect the set of RNA transcripts required for PMSD, and evaluate their impact on improved patient diagnosis and treatment. We will evaluate the effect of the PMSD approach in a pilot demonstration, by investigating healthcare resource utilization, costs, prediction of disease severity and outcomes of febrile illness to provide the evidence base for introduction of PMSD in European health systems.
Inclusion criteria:
- A patient of any age who attends or who is admitted at a participating hospital AND who has one or more of the following;
- Fever (≥38.0 °C) history of fever in the preceding 24 hours
- Symptoms (including non-specific signs) suggestive of infection
- 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.
- AND EITHER who gives consent for samples to be taken for research
- OR who retrospectively gives consent, according to a deferred consent model in which consent is obtained after initial sample collection (see section 4.2.4)
Exclusion criteria
- Patients who do not give consent
- RNA sample is not taken
What participating in the study involves?
Patients arrives at hospital with suspected infectious or inflammatory diseases. In order to identify these patients, a complete history and physical examination will be performed. If eligible blood samples will be taken.