WO2008058517A2 - Diagnose und risikostratifizierung von infektionen und chronischen erkrankungen der atemwege und lunge mittels provasopressin, insbesondere copeptin oder neurophysin ii - Google Patents

Diagnose und risikostratifizierung von infektionen und chronischen erkrankungen der atemwege und lunge mittels provasopressin, insbesondere copeptin oder neurophysin ii Download PDF

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Publication number
WO2008058517A2
WO2008058517A2 PCT/DE2007/002037 DE2007002037W WO2008058517A2 WO 2008058517 A2 WO2008058517 A2 WO 2008058517A2 DE 2007002037 W DE2007002037 W DE 2007002037W WO 2008058517 A2 WO2008058517 A2 WO 2008058517A2
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WIPO (PCT)
Prior art keywords
diagnosis
infections
chronic diseases
respiratory
risk stratification
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PCT/DE2007/002037
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German (de)
English (en)
French (fr)
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WO2008058517A3 (de
Inventor
Andreas Bergmann
Nils Morgenthaler
Jana Papassotiriou
Joachim Struck
Beat Müller
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BRAHMS GmbH
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BRAHMS GmbH
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Priority to EP07846321A priority Critical patent/EP2089718B1/de
Priority to US12/514,524 priority patent/US8158368B2/en
Priority to AT07846321T priority patent/ATE522814T1/de
Priority to JP2009535559A priority patent/JP5340160B2/ja
Publication of WO2008058517A2 publication Critical patent/WO2008058517A2/de
Publication of WO2008058517A3 publication Critical patent/WO2008058517A3/de
Anticipated expiration legal-status Critical
Priority to US13/425,928 priority patent/US20120270245A1/en
Priority to US15/180,797 priority patent/US10718783B2/en
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6884—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from lung
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/12—Pulmonary diseases
    • G01N2800/122—Chronic or obstructive airway disorders, e.g. asthma COPD
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/60—Complex ways of combining multiple protein biomarkers for diagnosis

Definitions

  • the invention relates to a method for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory tract and lungs, in particular of the deep respiratory tract infections (LRTI) and COPD ("chronic obstructive pulmonary disease”), wherein a determination of the provasopressin ( proAVP) or fragments and partial peptides thereof, especially copeptin or neurophysin II. Furthermore, the invention relates to suitable combinations of biomarkers for in-vitro diagnostics.
  • LRTI deep respiratory tract infections
  • COPD chronic obstructive pulmonary disease
  • Copeptin (also: C-terminal proAVP) is in WO 2006/018315 (BRAHMS AG) is described as a biomarker for the in-vitro diagnosis of heart disease and associated pulmonary disorders.
  • a related copeptin assay is described in Morgenthaler et al (Nils G. 5 Morgenthaler, Joachim Struck, Christine Alonso and Andreas Bergmann, Assay for the Measurement of Copeptin, a Stahle Peptide Derived from the Precursor of Vasopressin Clinical Chemistry 52: 112-119, 2006).
  • PCT procalcitonin
  • PCT is described in pneumonia (Prat et al 2006 (supra) and Masia M et al 2005 (supra), Boussekey N et al 2005 (supra), Christ Crain M, Morgenthaler NG, Pride D, Muller C, Bingisser R, Harbarth S, Tamm M, Struck J, Bergmann A, Muller B, Pro-adrenomedullin to predict
  • An object of the invention is therefore to provide a method for risk stratification for diagnosis and / or or to develop risk stratification of infections or chronic diseases of the respiratory and lungs, allowing improved detection of high-risk patients. Furthermore, it is disadvantageous that in the prior art usually no
  • a further object is, therefore, a method for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs
  • Combination of marker has a sufficient sensitivity and specificity.
  • the object is achieved by a method for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory tract and lungs, whereby a determination of the provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II (method according to the invention). ! 5
  • provasopressin proAVP
  • fragments and partial peptides thereof in particular copeptin or neurophysin II
  • provasopressin or fragments and partial peptides thereof, preferably copeptin or neurophysin II, have high sensitivity and specificity for the Diagnosis of infections or chronic respiratory and lung diseases.
  • infections of the lungs and respiratory tract are understood in particular as those caused by bacteria, viruses, fungi or parasites, for example such indications as lower respiratory tract infections (LRTI), bronchitis, pneumonia, sarcoidosis , Bronchiectasis, non-cardiac pulmonary edema.
  • LRTI lower respiratory tract infections
  • bronchitis pneumonia
  • sarcoidosis bronchita
  • Bronchiectasis non-cardiac pulmonary edema.
  • LRTI deep respiratory tract infections
  • bronchitis bronchitis
  • putrid bronchitis preferably bronchitis
  • pneumonia preferably a chronic respiratory tract infection (LRTI)
  • CAP community-acquired pneumonia
  • LRTI deep respiratory tract infections
  • pneumonia is understood as meaning an acute or chronic disease of the lung tissue and its infection is caused by bacteria, viruses or fungi, parasites, rarely also toxic by inhalation of toxic substances or immunologically.
  • pneumonia is a constellation of various symptoms (fever or hypothermia, chills, cough, pleuritic chest pain, increased sputum production, increased
  • chronic diseases 5 of the lungs and respiratory tract are understood to mean such indications as interstitial lung diseases and pulmonary fibrosis, chronic obstructive pulmonary diseases (COPD), in particular COPD infection exacerbations, bronchial asthma, especially infectious exacerbations in bronchial asthma, .0 Especially preferred is COPD, especially COPD infection exacerbations.
  • COPD chronic obstructive pulmonary diseases
  • COPD denotes a group of chronic diseases characterized by coughing, increased expectoration and respiratory distress
  • .0 is also a "smoker's cough.”
  • the invention is particularly advantageous in acute exacerbations.
  • the term "risk stratification” encompasses finding patients, in particular emergency patients and patients at risk, with the worse prognosis, for more intensive diagnostics and therapy / treatment of infections or chronic diseases of the respiratory and lungs with the aim of the most favorable course possible enable.
  • a risk stratification according to the invention allows an effective treatment method which is given in the case of infections or chronic diseases of the respiratory tract and lungs with medicaments, in particular antibiotics.
  • the invention also relates to the identification of patients at increased risk or / and unfavorable prognosis of infections or chronic diseases of the airway and lungs in symptomatic and / or asymptomatic patients, especially emergency patients.
  • the method according to the invention therefore makes possible clinical decisions which lead to rapid therapeutic success and to the avoidance of death.
  • Such a clinical decision according to the invention also includes the
  • the invention therefore also relates to a method for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory tract and lungs for carrying out clinical decisions, such as further treatment and therapy by means of medicaments, in particular antibiotics, preferably in time-critical intensive care or emergency medicine.
  • the method according to the invention therefore relates to the therapy control of infections or chronic diseases of the respiratory and lungs.
  • the diagnosis and / or risk stratification takes place for the prognosis
  • the invention relates to a method for in vitro diagnosis and / or
  • provasopressin provasopressin
  • a determination of the marker provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II, is carried out on a patient to be examined.
  • copeptin or a fragment or a partial sequence thereof.
  • copeptin exhibits advantageous high serum and plasma stability for in vitro diagnostic use (Morgenthaler NG, Struck J, Alonso C, et al., Assay for the measurement of copeptin, a stable peptide
  • the invention relates to a method for diagnosis and / or risk stratification of infections or chronic respiratory and pulmonary diseases or an in vitro diagnostic method for the early or differential diagnosis or prognosis of infections or chronic respiratory and lung diseases according to any of the above embodiments, wherein after the onset of symptoms a cut-off (Threshold) range of ⁇ -20 pmol / L of the provasopressin (proAVP) markers or fragments and partial peptides thereof, in particular copeptin or neurophysin II is significant (specific) for the diagnosis and / or risk stratification. Also preferred is a cut-off (threshold) of 6-10 pmol / L, in particular 9 pmol / L, preferably up to 2 hours after onset of symptoms.
  • a cut-off (threshold) 6-10 pmol / L, in particular 9 pmol / L, preferably up to 2 hours after onset of symptoms.
  • the invention further relates to a method for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs or a method for in vitro diagnostics for the early or differential diagnosis or prognosis of infections or chronic diseases of the respiratory and lung according to one of the above embodiments wherein, after onset of symptoms, a cut-off (threshold) range of 10-50 pmol / L of provasopressin (proAVP) marker or fragments and partial peptides thereof, in particular copeptin or neurophysin II is significant (specific) for prognosis and / or risk stratification , Further preferred is a cut-off (threshold) of 10-40 pmol / L.
  • provasopressin provasopressin
  • body fluid in particular blood
  • body fluid is taken from the patient to be examined, optionally whole blood or serum or available plasma, and the diagnosis is made in vitro / ex vivo, ie. outside the human or animal body.
  • provasopressin proAVP
  • fragments and partial peptides thereof in particular copeptin or neurophysin II
  • a high sensitivity and specificity for infections or chronic diseases of the respiratory and lung is achieved and based on the amount present in at least one patient sample the diagnosis or risk stratification respectively.
  • the marker copeptin (stable fragment of proAVP or preprovasopressin) or a fragment or a partial sequence thereof is very particularly preferred.
  • provasopressin is understood to mean a human protein or polypeptide which can be obtained from the preprovasopressin and comprises amino acids 29-164 in the context of the preprovasopressin (see also WO2006 / 018315 and FIG.
  • copeptin fragment: AS 126-164 (39AS: SEQ: ASDRSNATQL DGPAGALLLR LVQLAGAPEP FEPAQPDAY) or Neurophysin II (fragment: AS 32-124 of preprovasopressin (93AS: SEQ: AMSDLELRQC LPCGPGGKGR CFGPSICCAD ELGCFVGTAE ALRCQEENYL PSPCQSGQKA CGSGGRCAAF GVCCNDESCV TEPECREGFH RRA).
  • these polypeptides of the invention may have post-translational modifications, such as glycosylation, lipidization or derivatizations. 5
  • provasopressin or fragments and partial peptides thereof, in particular copeptin or neurophysin II can additionally be carried out with further markers, preferably those which already point to infections or chronic diseases of the respiratory tract and lungs.
  • the invention relates to such an embodiment of the method according to the invention, wherein the determination additionally L5 is carried out with at least one further marker selected from the group of inflammatory markers on a patient to be examined.
  • the inflammatory marker of -0 at least one marker from the group C-reactive protein
  • CRP cytokines
  • TNF-alpha cytokines
  • interleukins such as IL-6
  • procalcitonin (1-116, 3-116)
  • adhesion molecules such as VCAM or ICAM.
  • the invention relates to a particularly advantageous combination of biomarkers namely provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II with procalcitonin (1-116, 3-116) and / or the group C-reactive protein (CRP).
  • biomarkers namely provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II with procalcitonin (1-116, 3-116) and / or the group C-reactive protein (CRP).
  • the invention therefore relates to a method for the in-vitro diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs, wherein a determination of the marker ProVasopressin (proAVP) or fragments and partial peptides thereof, in particular Copeptin or Neurophysin II in combination with Procalcitonin ( 1-116, 3-116) or a subsequence thereof, to be examined
  • ProAVP ProVasopressin
  • Copeptin or Neurophysin II in combination with Procalcitonin ( 1-116, 3-116) or a subsequence thereof
  • procalcitonin is understood as meaning a human protein or polypeptide with a
  • the procalcitonin according to the invention may have post-translational modifications, such as glycation, lipidification or derivatizations. Also included are partial sequences or fragments of procalcitonin.
  • the method according to the invention can be carried out as part of an in-vitro diagnosis by means of parallel or simultaneous determinations of the markers (eg multi-well plates with 96 and more cavities), the determinations being carried out on at least one patient sample.
  • the method according to the invention and its determinations can be carried out in a diagnostic device by means of an automatic analyzer, in particular by means of a cryptor (http://www.kryptor.net/).
  • the method according to the invention and its determinations can be carried out by means of a rapid test (for example, lateral-flow test), be it in
  • Single or multi-parameter determination is a self-test or a device that is suitable in emergency diagnostics.
  • the invention relates to the use of provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II for the in-vitro diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs and / or for in vitro diagnostics for the early or differential diagnosis or prognosis of infections or chronic diseases of the respiratory and lungs.
  • provasopressin proAVP
  • copeptin or neurophysin II for the in-vitro diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs and / or for in vitro diagnostics for the early or differential diagnosis or prognosis of infections or chronic diseases of the respiratory and lungs.
  • the invention relates to the use of provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or neurophysin II in combination with procalcitonin (1-116, 3-116) or in each case a partial sequence thereof, for diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs.
  • provasopressin proAVP
  • copeptin or neurophysin II in combination with procalcitonin (1-116, 3-116) or in each case a partial sequence thereof, for diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs.
  • the use according to the invention can optionally be carried out with at least one further suitable marker (so-called “panel” or “cluster”).
  • Another object is to provide a corresponding diagnostic device for carrying out the method according to the invention.
  • such a diagnostic device in particular an array or assay (for example immunoassay, ELISA, etc.), is understood in the broadest sense as an apparatus for carrying out the methods according to the invention.
  • an array or assay for example immunoassay, ELISA, etc.
  • the invention also relates to a kit for the diagnosis and / or risk stratification of infections or chronic diseases of the respiratory and lungs, containing detection reagents for the determination of provasopressin (proAVP) or fragments and partial peptides thereof, in particular copeptin or Neurophysin II, if necessary, the other markers mentioned above.
  • detection reagents include, for example, antibodies, etc.
  • Example 1 Patients who presented with the main symptom of respiratory distress in the hospital emergency department were sampled during the initial examination. Number of subjects: 167
  • Copeptin assay according to Morgenthaler et al (Morgenthaler NG, Struck J, Alonso C, et al., Assay for the measurement of copeptin, a stable peptide derived from the precursor of vasopressin, Clin Chem 2006; 52: 112-119) Detection limit; 1.7 pmol / L,
  • Copeptin values of 167 patients were studied. The patients came to the emergency department with acute exacerbation of existing COPD. Patients were clinically examined for lung function at admission, at 14 days, and at 6 months. Table 1 gives an overview of the clinical parameters of the patients when admitted to the emergency department.
  • Figure 1 shows the amino acid sequence of preproVasopressin.
  • FIG. 2 shows the relationship between hospital stays of patients with CAP / pneumonia and the measured copeptin plasma value on admission. This is shown as probability of hospital discharge over time (patients with copeptin values ⁇ 40) pmol / 1 on admission had a significantly shorter inpatient stay compared to patients with copeptin levels> 40 pmol / 1.
  • FIG. 3 shows the relationship between the frequency of complications (death, re-admission after discharge) and the copeptin plasma value at admission. This is shown as an event free time (freedom of event). event

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PCT/DE2007/002037 2006-11-12 2007-11-11 Diagnose und risikostratifizierung von infektionen und chronischen erkrankungen der atemwege und lunge mittels provasopressin, insbesondere copeptin oder neurophysin ii Ceased WO2008058517A2 (de)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP07846321A EP2089718B1 (de) 2006-11-12 2007-11-11 Diagnose und risikostratifizierung von infektionen und chronischen erkrankungen der atemwege und lunge mittels provasopressin, insbesondere copeptin oder neurophysin ii
US12/514,524 US8158368B2 (en) 2006-11-12 2007-11-11 Diagnosis and risk stratification of infections and chronic diseases of the respiratory tract and lungs by means of provasopressin, particularly copeptin or neurophysin II
AT07846321T ATE522814T1 (de) 2006-11-12 2007-11-11 Diagnose und risikostratifizierung von infektionen und chronischen erkrankungen der atemwege und lunge mittels provasopressin, insbesondere copeptin oder neurophysin ii
JP2009535559A JP5340160B2 (ja) 2006-11-12 2007-11-11 プロバソプレシン、特にコペプチンもしくはニューロフィジンｉｉによる、気道および肺の感染および慢性疾患の診断および／または危険性の層化
US13/425,928 US20120270245A1 (en) 2006-11-12 2012-03-21 Diagnosis and risk stratification of infections and chronic diseases of the respiratory tract and lungs by means of provasopressin, particularly copeptin or neurophysin ii
US15/180,797 US10718783B2 (en) 2006-11-12 2016-06-13 Diagnosis and risk stratification of infections and chronic diseases of the respiratory tract and lungs by means of provasopressin, particularly copeptin or neurophysin II

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DE102006053442A DE102006053442A1 (de) 2006-11-12 2006-11-12 Diagnose und Risikostratifizierung von Infektionen und chronischen Erkrankungen der Atemwege und Lunge mittels proVasopressin, insbesondere Copeptin oder Neurophysin II
DE102006053442.5 2006-11-12

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US12/514,524 A-371-Of-International US8158368B2 (en) 2006-11-12 2007-11-11 Diagnosis and risk stratification of infections and chronic diseases of the respiratory tract and lungs by means of provasopressin, particularly copeptin or neurophysin II
US13/425,928 Continuation US20120270245A1 (en) 2006-11-12 2012-03-21 Diagnosis and risk stratification of infections and chronic diseases of the respiratory tract and lungs by means of provasopressin, particularly copeptin or neurophysin ii

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AT (1) ATE522814T1 (enExample)
DE (1) DE102006053442A1 (enExample)
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US8158368B2 (en) 2012-04-17
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US20170059583A1 (en) 2017-03-02
JP6170101B2 (ja) 2017-07-26
EP2378290B1 (de) 2017-05-03
HK1215731A1 (zh) 2016-09-09
ES2634137T3 (es) 2017-09-26
JP2013083664A (ja) 2013-05-09
JP2010509576A (ja) 2010-03-25
US20120270245A1 (en) 2012-10-25
DK2378290T3 (en) 2017-07-31
JP2016026286A (ja) 2016-02-12
US10718783B2 (en) 2020-07-21
ES2370071T3 (es) 2011-12-12
JP5340160B2 (ja) 2013-11-13
DE102006053442A1 (de) 2008-05-15
CN101563613A (zh) 2009-10-21
WO2008058517A3 (de) 2008-10-23

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