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Risk Stratification Using Midregional Proadrenomedullin in the ED

Primary Purpose

Patients Presenting With Suspicion of Infection to the ED

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MR-proADM KRYPTOR

About this trial

This is an interventional other trial for Patients Presenting With Suspicion of Infection to the ED

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Dependents of the sponsor, the CRO, the study site or the investigator

Sites / Locations

Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne UniversitéRecruiting
Policlinico Tor VergataRecruiting
Hospital Santa Maria della MisericordiaRecruiting
Hospital Universitario Central de Asturias (HUCA)Recruiting
Hospital ClinicRecruiting
Hospital Clinico San CarlosRecruiting
Hospital Virgen de la MacarenaRecruiting
Hampshire Hospitals NHS Foundation TrustRecruiting
University Hospital Southampton NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care arm

MR-proADM guided arm

Arm Description

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols

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

Outcomes

Primary Outcome Measures

Number of out-patients re-presenting to the ED

Secondary Outcome Measures

Full Information

NCT ID

NCT05108883

First Posted

October 18, 2021

Last Updated

April 20, 2023

Sponsor

Brahms AG

1. Study Identification

Unique Protocol Identification Number

NCT05108883

Brief Title

Risk Stratification Using Midregional Proadrenomedullin in the ED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 14, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brahms AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients Presenting With Suspicion of Infection to the ED

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

452 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard care arm

Arm Type

No Intervention

Arm Description

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols

Arm Title

MR-proADM guided arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MR-proADM KRYPTOR

Intervention Description

MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

Primary Outcome Measure Information:

Title

Number of out-patients re-presenting to the ED

Description

Number of out-patients re-presenting to the ED

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Dependents of the sponsor, the CRO, the study site or the investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Faranak Fassihianifard

Phone

00493302883

Ext

faranak.fassihianifard@thermofisher.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stefan Ebmeyer, MD

Phone

00493302883

Ext

stefan.ebmeyer@thermofisher.com

Facility Information:

Facility Name

Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université

City

Paris

ZIP/Postal Code

75651

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Hausfater, MD, PhD

Facility Name

Policlinico Tor Vergata

City

Roma

ZIP/Postal Code

00133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacopo Maria Legramante, MD

Facility Name

Hospital Santa Maria della Misericordia

City

Udine

ZIP/Postal Code

33100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlo Tascini, MD

Facility Name

Hospital Universitario Central de Asturias (HUCA)

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pablo Herrero Puente, MD

Facility Name

Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mar Ortega, MD

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan González del Castillo, MD

Facility Name

Hospital Virgen de la Macarena

City

Seville

ZIP/Postal Code

41009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carmen Navarro Bustos, MD

Facility Name

Hampshire Hospitals NHS Foundation Trust

City

Basingstoke

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Moore, MD

Facility Name

University Hospital Southampton NHS Foundation Trust

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kordo Saeed, MD

12. IPD Sharing Statement

Learn more about this trial

Risk Stratification Using Midregional Proadrenomedullin in the ED

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