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

摘要

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.

主权项

1. A method for diagnosing whether a subject suffering from a primary non-infectious disease has an increased risk of an adverse outcome induced by administration of an antibiotic in order to treat potential bacterial infections to said subject, comprising:
(a) detecting and quantifying in a sample of a blood from the subject the level of Procalcitonin (PCT) or a fragment thereof having an amino acid sequence 2-116 or 3-116 of the PCT of SEQ ID NO:1, wherein said detection and quantitation comprises
i. contacting said sample with a diagnostic assay capture molecule which specifically binds to the PCT or fragment, andii. quantitating the capture molecule:PCT or fragment thereof complex,thereby determining the level of the PCT or fragment thereof in the sample; (b) comparing the thus-determined level of PCT or fragment thereof in the sample with a predetermined value obtained by a statistical analysis of calibration levels for the prediction of a potential risk of an adverse outcome induced by the administration of an antibiotic;wherein the predetermined value resulting from the statistical analysis indicate a statistically significant adverse outcome risk if the sample contains less than 200 pg/mL of PCT or fragment thereof, whereby if the sample contains less than 200 pg/mL of PCT or fragment thereof, said subject is diagnosed as having a statistically significant increased risk of having an adverse outcome induced by administration of an antibiotic in order to treat or prevent potential bacterial infections, andwherein
when the subject is determined to have a statistically significant risk of an adverse outcome, treatment which excludes administration of antibiotics in order to treat potential bacterial infections is performed, and when the subject is determined to not have a statistically significant risk of an adverse outcome, administration of antibiotics in order to treat potential bacterial infections is performed.