Risk Stratification Using Midregional Proadrenomedullin in the ED

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

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.

Study Overview

• Status: Completed
• Conditions: Patients Presenting With Suspicion of Infection to the ED
• Intervention / Treatment: Device: MR-proADM KRYPTOR

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75651
    • Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université
• Italy
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
  • Udine, Italy, 33100
    • Hospital Santa Maria Della Misericordia
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Seville, Spain, 41009
    • Hospital Virgen de la Macarena
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias (HUCA)
• United Kingdom
  • Basingstoke, United Kingdom, RG24 9NA
    • Hampshire Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care arm; decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols
Experimental: MR-proADM guided arm; decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels	Device: MR-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of out-patients re-presenting to the ED	Number of out-patients re-presenting to the ED	5 days

Collaborators and Investigators

• Sponsor: Brahms AG

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): November 7, 2023
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: IDEAL+ Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No