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DIAMONDS-SEARCH study: Designing new tests that can diagnose the causes of fever, including COVID-19

Diagnosis and management of febrile illness using RNA personalised molecular signature diagnosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12394803
Enrollment
5000
Registered
2020-06-22
Start date
2020-04-27
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with suspected infection or suspected inflammatory conditions including patients with suspected COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

The researchers will use case-controlled groups of patients presenting to hospital, recruited across Europe, The Gambia and Asia to discover biomarkers of infectious and inflammatory disease, using mu

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactFederico Martinón-Torres
Federico.Martinon.Torres@sergas.es+34 (0)981 955373

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026