US 12,265,092 B2Granted

Workflow for risk assessment and patient management using procalcitonin and midregional-proadrenomedullin

AssigneeB.R.A.H.M.S GmbH

InventorsAline Pehla, Darius Wilson

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Abstract

The present invention is in the field of clinical diagnostics. Particularly, the present invention relates to the assessment of severity of a subject being suspected of an infection or having an infection, who may have physiological signs or increased risk factors for infection, in particular from an infectious disease by determination of the levels of Procalcitonin (hereinafter: PCT) (SEQ ID No: 1 and/or proadrenomedullin (hereinafter: proADM)) (SEQ ID No: 3) or a partial peptide or fragment thereof, in particular midregional proadrenomedullin (MR-proADM) (SEQ ID No: 2), in a sample of a patient and the invention is related to a workflow hereto. Moreover, the invention refers to the assessment related to an infection like ruling out/in a patient and stratification, risk assessment, in particular to avoid rehospitalisation and hospital and post-discharge mortality.

A method of treatment comprising:

(i) preparing a single sample of a bodily fluid from one subject suspected of an infection, or having an infection;
(ii) determining in said sample:
a level of Procalcitonin (PCT) or a fragment or precursor thereof, wherein said fragment or precursor thereof has a length of at least 12 amino acid residues, and
a level of proadrenomedullin (proADM) or a fragment thereof, having a length of at least 12 amino acid residues, and
(iii) determining the severity of the infection of the subject, by comparing said determined PCT level and proADM level, or said level of said fragment(s) or precursors, with threshold levels,
wherein said determined PCT and proADM levels, or said levels of said fragment(s) or precursors, are compared to the PCT and proADM threshold levels of one or more of the following features (iv) to (vi),
(iv) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 0.88 nmol/L, and not equal or higher than 1.5 nmol/L,
or,
(v) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 1.50 nmol/L, and not equal or higher than 2.25 nmol/L,
or,
(vi) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 2.25 nmol/L,
wherein the conditions of at least one of (iv), (v) or (vi) are met, and
if (iv) is applicable, hospitalizing and administering an antibiotic to the subject,
if (v) is applicable, hospitalizing and intravenously administering an antibiotic to the subject, and additionally determining a level of PCT or fragment or precursor thereof within 24 hours, or
if (vi) is applicable, admitting the patient to an intensive care unit (ICU), immediately intravenously administering an antibiotic to the subject and monitoring organ dysfunction of the patient in the ICU.

12 more elements

Facts

Application

16/956,036Filed 20 Dec 2018

Priority

EP 1720915120 Dec 2017

Published

US 2021/0109117 A115 Apr 2021

Granted

1 Apr 2025

Term ends

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Classification6 codes

G01N 33/74
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing:…
G01N 2333/58
Hormones: atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin;…
G01N 2333/585
Hormones: calcitonins
G01N 2800/26
Detection or diagnosis of diseases: infectious diseases, e.g. generalised sepsis

Abstract

Claims8