Risk Stratification Using Midregional Proadrenomedullin in the ED

Patients Presenting With Suspicion of Infection to the ED Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108883
• Other study ID #: IDEAL+ Study
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Brahms AG
• Contact: Faranak Fassihianifard
• Phone: 00493302883
• Email: faranak.fassihianifard[@]thermofisher.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Patients Presenting With Suspicion of Infection to the ED

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université	Paris
Italy	Policlinico Tor Vergata	Roma
Italy	Hospital Santa Maria della Misericordia	Udine
Spain	Hospital Clinic	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Central de Asturias (HUCA)	Oviedo	Asturias
Spain	Hospital Virgen de la Macarena	Seville
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Basingstoke
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Brahms AG

Countries where clinical trial is conducted

France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of out-patients re-presenting to the ED	Number of out-patients re-presenting to the ED	5 days