A method
AssigneeOwlstone Medical Limited
InventorGiuseppe FERRANDINO
Life of this patent
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Abstract
A method for identifying a patient having reduced liver-function or a patient at risk of reduced liver function that will respond to therapy with an antibiotic and/or antifungal agent comprising measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample from said patient, wherein the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker is indicative that said patient will respond to therapy with an antibiotic and/or antifungal agent.
Claims132
A method for identifying a patient having reduced liver-function or a patient at risk of reduced liver function that will respond to therapy with an antibiotic and/or antifungal agent comprising measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample from said patient, wherein the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker is indicative that said patient will respond to therapy with an antibiotic and/or antifungal agent.
A method of predicting a response to an antibiotic and/or antifungal agent therapy in a patient having reduced liver-function or at risk of reduced liver function comprising measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample from said patient, wherein the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker is indicative of a response or non-response of a patient to therapy with an antibiotic and/or antifungal agent.
The method according to any preceding claim, wherein the direct ethanol biomarker is ethyl sulphate, ethyl-glucuronide, fatty acid ethyl esters, phosphatidylethanol, and/or combinations thereof.
The method according to any preceding claim wherein the sugar fermentation product is pyruvate, formic acid and/or ester derivates thereof, acetylphosphate, acetylaldehyde, hydroxyethyl-thiamine pyrophosphate (hydroxyethyl-TPP), acetyllactate, acetoin, 2,3-butanediol and/or combinations thereof, for example 2,3-butanediol.
The method according to any preceding claim, wherein the method comprises measuring the concentration of ethanol in a biological sample from said patient.
The method according to any preceding claim, wherein the patient has been diagnosed with a liver disease.
The method according to any preceding claim, further comprising the step of identifying a patient in need of treatment with an antibiotic and/or antifungal agent.
The method according to any preceding claim, further comprising the step of obtaining a biological sample from the patient.
The method according to any preceding claim, wherein the biological sample is hair, blood, stool, urine and/or exhaled breath.
The method according to any preceding claim, further comprising administering a carbohydrate to the patient.
The method according to any preceding claim, further comprising the step of administering an alcohol dehydrogenase (ADH) inhibitor to the patient.
The method according to any preceding claim, wherein the biological sample is blood and a concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker of at least 20 mmol/L is indicative that said patient will respond to therapy with an antibiotic and/or antifungal agent.
The method according to any preceding claim, wherein the biological sample is exhaled breath and a concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker of at least 0.0025 mmol/L is indicative that said patient will respond to therapy with an antibiotic and/or antifungal agent.
The method according to any preceding claim, wherein the ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker is labelled.
The method according to any preceding claim, wherein the antibiotic comprises rifaximin;
- neomycin;
- metronidazole;
- flouroquinolones;
- cephalosporins;
- trimethoprim-sulfamethoxazole;
- flucloxacillin;
- cephalothin;
- aztreonam;
- cabimicina;
- and combinations thereof;
- and/or wherein the antifungal agent comprises clotrimazole, econazole, miconazole, terbinafine, fluconazole, ketoconazole, nystatin, amphotericin, and/or combinations thereof.
A method of treating a patient with reduced liver function, the method comprising the steps of:
- a) measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient;
- and
- b) predicting a response to treatment with an antibiotic and/or antifungal agent by comparing the concentration to a reference value from a subject with reduced liver function that does not respond to therapy with an antibiotic and/or antifungal agent;
- and/or from a subject with reduced liver function that does respond to therapy with an antibiotic and/or antifungal agent;
- and/or from a healthy subject;
- wherein if the reference level is from a subject that does not respond to therapy with an antibiotic and/or antifungal agent, then an increase in the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker compared to the reference value is indicative that the patient will respond to therapy with an antibiotic and/or antifungal agent;
- wherein if the reference level is from a subject that does respond to therapy with an antibiotic and/or antifungal agent, then the same or substantially the same or an increase in concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker is indicative that the patient will respond to therapy with an antibiotic and/or antifungal agent;
- or wherein if the reference level is from a healthy, then an increase in the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker compared to the reference value is indicative that the patient will respond to therapy with an antibiotic and/or antifungal agent;
- and
- c) if the patient is predicted to respond to therapy with an antibiotic and/or antifungal agent, administering an antibiotic and/or antifungal agent to the patient.
A method for identifying a patient having reduced liver-function or a patient at risk of reduced liver function that will respond to therapy with an antibiotic and/or antifungal agent, comprising the steps of:
- a) establishing a reference value by measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient before a carbohydrate has been administered;
- b) administering a carbohydrate to the patient;
- c) establishing a test value by measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient after the carbohydrate has been administered;
- and
- d) comparing the reference value to the test value, wherein the reference value is the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient before a carbohydrate has been administered;
- wherein the difference in the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in the test value compared to the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in the reference value is indicative that said patient will respond to therapy with an antibiotic antifungal agent if said difference is above a threshold value.
A method of treating a patient with reduced liver function, the method comprising the steps of:
- a) establishing a reference value by measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient before a carbohydrate has been administered;
- b) administering a carbohydrate to the patient;
- c) establishing a test value by measuring the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient after the carbohydrate has been administered;
- d) comparing the reference value to the test value, wherein the reference value is the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in a biological sample obtained from the patient before a carbohydrate has been administered, and wherein the difference in the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in the test value compared to the concentration of ethanol, one or more sugar fermentation product, such as 2,3-butanediol, and/or a direct ethanol biomarker in the reference value is indicative that said patient will respond to therapy with an antibiotic and/or antifungal agent if said difference is above a threshold value;
- and
- e) if the patient is predicted to respond to therapy with an antibiotic and/or antifungal agent, administering an antibiotic and/or antifungal agent to the patient.
The method according to any one of claim 106 or 107, wherein the direct ethanol biomarker is ethyl sulphate, ethyl-glucuronide, fatty acid ethyl esters, phosphatidylethanol, and/or combinations thereof.
Dependencies are inferred from the claim text.