Patients Presenting With Suspicion of Infection to the ED
Conditions
Brief summary
Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED. The rationale of this IDEAL+ study is to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.
Interventions
DEVICEMR-proADM KRYPTOR
MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized
Sponsors
Brahms AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consecutive patients presenting to the ED with suspicion of infection 2. Age ≥18 years 3. Written Informed Consent obtained
Exclusion criteria
1. Patients with SARS-COV-2 infection 2. Recent major trauma or surgery 3. End stage renal failure requiring dialysis 4. Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure 5. Patients whose source of infection always requires hospital admission or never requires hospital admission. 6. Patients who cannot be discharged for other than medical reasons 7. Patient participates in any other interventional clinical trial 8. Patients with active abusive drug use 9. Pregnant or lactating women 10. Patients who are institutionalized by official or judicial order 11. Dependents of the sponsor, the CRO, the study site or the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of out-patients re-presenting to the ED | 5 days | Number of out-patients re-presenting to the ED |
Countries
France, Italy, Spain, United Kingdom
Outcome results
None listed