Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis

Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis - DIAMONDS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54367

Enrollment

1800

Registered

2021-01-19

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Febrile illness fever

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: Patients admitted to clinical ward or presenting to the emergency room of one of the participating hospitals presenting with fever or clinical suspicion of infection in whom the attending clinician determines the need for blood sampling.

Exclusion criteria

Exclusion criteria: Patients who do not give consent

Design outcomes

Primary

Measure	Time frame
DIAMONDS SEARCH We will discover and validate RNA-based biomarkers that distinguish children and adults with infectious and inflammatory conditions. DIAMONDS PILOT DEMONSTRATION Practicality of personalised molecular signature diagnosis in clinical departments.	—

Secondary

Measure	Time frame
DIAMONDS SEARCH We will collect detailed resource-use data on patients presenting to healthcare services with infectious and inflammatory illness. We will capture detailed information on the clinical presentation, patient management and final outcome, and we will correlate this information with biomarker findings. DIAMONDS PILOT DEMONSTRATION 1. Demonstrate the practical utility of a prototype PMSD device in a real clinical setting, and its robustness (sensitivity, specificity, predictive value). 2. Demonstrate the potential clinical impact of a PMSD device on time to diagnosis, accuracy of diagnosis, resource use, or inappropriate antibiotic use in the patients recruited. 3. Gather pilot data to support the introduction of PMSD testing as part of clinical care in European countries. WP9 will use these data to model the impact of PMSD on replacement of current diagnostics, decision-making for initial treatment, and admission, thus calculating patient and societal benefits.	—

Measure

Time frame

DIAMONDS SEARCH We will collect detailed resource-use data on patients presenting to healthcare services with infectious and inflammatory illness. We will capture detailed information on the clinical presentation, patient management and final outcome, and we will correlate this information with biomarker findings. DIAMONDS PILOT DEMONSTRATION 1. Demonstrate the practical utility of a prototype PMSD device in a real clinical setting, and its robustness (sensitivity, specificity, predictive value). 2. Demonstrate the potential clinical impact of a PMSD device on time to diagnosis, accuracy of diagnosis, resource use, or inappropriate antibiotic use in the patients recruited. 3. Gather pilot data to support the introduction of PMSD testing as part of clinical care in European countries. WP9 will use these data to model the impact of PMSD on replacement of current diagnostics, decision-making for initial treatment, and admission, thus calculating patient and societal benefits.

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Countries

Netherlands

Outcome results