Risk assessment for antibiotics treatment in patients suffering from primary non-infectious disease by determining the level of procalcitonin

Abstract

A diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of an adverse outcome potentially being induced by the administration of an antibiotic to said subject comprising the determination of the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having a length of at least 12 amino acid residues in a sample of a bodily fluid from said subject and the correlation of the determined level to a potential risk induced by the administration of an antibiotic, as well as a kit for performing the method and methods of treatment based thereon.

1 . Diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of an adverse outcome potentially being induced by the administration of an antibiotic to said subject, comprising the steps of:
 (i) providing a sample of a bodily fluid from said subject suffering from a primary non-infectious disease,   (ii) determining in said sample the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having a length of at least 12 amino acid residues,   (iii) correlating the determined level to a potential risk induced by the administration of an antibiotic.   
     
     
         2 . Diagnostic method according to  claim 1 , wherein said outcome is an adverse event. 
     
     
         3 . Diagnostic method according to  claim 1 , wherein said outcome is mortality. 
     
     
         4 . Diagnostic method according to  claim 1 , wherein said subject has a primary non-infectious disease selected from the group of cardiovascular disease, cardiac disease, cancer, a disease of the CNS, diabetes, autoimmune disorder, and disorder associated with inflammation. 
     
     
         5 . Diagnostic method according to  claim 1 , wherein said primary disease is congestive heart failure. 
     
     
         6 . Diagnostic method according to  claim 5 , wherein said primary disease is acute heart failure. 
     
     
         7 . Diagnostic method according to  claim 5 , wherein said primary disease is chronic heart failure. 
     
     
         8 . Diagnostic method according to  claim 1 , wherein a concentration of PCT or a fragment thereof or a precursor or fragment thereof below 200 pg/mL in said sample correlates to an increased risk induced by the potential administration of an antibiotic. 
     
     
         9 . Diagnostic method according to  claim 1 , wherein a concentration of PCT or a fragment thereof or a precursor or fragment thereof below 50 pg/mL in said sample correlates to an increased risk induced by the potential administration of an antibiotic. 
     
     
         10 . Diagnostic method according to  claim 1 , further comprising stratification of subjects suffering from a primary non-infectious disease into a group of subjects having an increased risk of an adverse outcome induced by the administration of an antibiotic and a group of subjects having no risk induced by the administration of an antibiotic. 
     
     
         11 . A kit comprising one or more antibodies directed against PCT or a fragment thereof or a precursor or fragment thereof for the stratification of subjects suffering from a primary non-infectious disease into a group of subjects having an increased risk of an adverse outcome induced by the administration of an antibiotic and a group of subjects having no risk induced by the administration of an antibiotic.