IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study

Brahms AG9 sites in 4 countries463 target enrollmentOctober 14, 2021

ConditionsPatients Presenting With Suspicion of Infection to the ED

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients Presenting With Suspicion of Infection to the ED
Sponsor: Brahms AG
Enrollment: 463
Locations: 9
Primary Endpoint: Number of out-patients re-presenting to the ED
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2021

End Date

November 7, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brahms AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Consecutive patients presenting to the ED with suspicion of infection
•Age ≥18 years
•Written Informed Consent obtained

Exclusion Criteria

•Patients with SARS-COV-2 infection
•Recent major trauma or surgery
•End stage renal failure requiring dialysis
•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
•Patients whose source of infection always requires hospital admission or never requires hospital admission.
•Patients who cannot be discharged for other than medical reasons
•Patient participates in any other interventional clinical trial
•Patients with active abusive drug use
•Pregnant or lactating women
•Patients who are institutionalized by official or judicial order