Methods for treatment of bacterial infections in impaired renal patients

Abstract

The invention provides methods for treatment of bacterial infections in impaired renal patients. Methods of the invention include administration of a therapeutically effective dose of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue.

1 . A method for treating a bacterial infection in an impaired renal patient in need thereof, the method comprising the steps of: 
 selecting an impaired renal patient;    providing a therapeutically effective dose of a pharmaceutical composition comprising dalbavancin; and    administering the therapeutically effective dose to the patient in need thereof.    
     
     
         2 . The method of  claim 1 , wherein the therapeutically effective dose is between about 300 mg and about 1200 mg.  
     
     
         3 . The method of  claim 1 , wherein the therapeutically effective dose is about 500 mg.  
     
     
         4 . The method of  claim 1 , wherein the therapeutically effective dose is about 1000 mg.  
     
     
         5 . The method of  claim 1 , wherein the therapeutically effective dose achieves a peak concentration in the patient (C max ) of at least 100 mg/L.  
     
     
         6 . The method of  claim 1 , wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L.  
     
     
         7 . The method of  claim 1 , wherein the patient receives a single dose, wherein the dose achieves a peak concentration in the patient (C max ) of at least 100 mg/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 42 mg/L.  
     
     
         8 . The method of  claim 1 , wherein the patient receives a single dose, wherein the dose achieves a peak concentration in the patient (C max ) of at least 100 mg/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 45 mg/L.  
     
     
         9 . The method of  claim 1 , wherein the patient receives a single dose, wherein the dose achieves a peak concentration in the patient (C max ) of at least 100 mg/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 50 mg/L.  
     
     
         10 . The method of  claim 1 , wherein the patient receives a single dose, wherein the dose achieves a peak concentration in the patient (C max ) of at least 100 mg/L, and wherein a Dalbavancin plasma level at 14 days post administration is at least 25 mg/L.  
     
     
         11 . The method of  claim 1 , wherein the patient receives a single dose, wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 42 mg/L.  
     
     
         12 . The method of  claim 1 , wherein the patient receives a single dose, wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 42 mg/L.  
     
     
         13 . The method of  claim 1 , wherein the patient receives a single dose, wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 45 mg/L.  
     
     
         14 . The method of  claim 1 , wherein the patient receives a single dose, wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L, and wherein a Dalbavancin plasma level at 7 days post administration is at least 50 mg/L.  
     
     
         15 . The method of  claim 1 , wherein the patient receives a single dose, wherein the therapeutically effective dose achieves a patient exposure (area under the curve) of at least 13,000 mg·h/L, and wherein a Dalbavancin plasma level at 14 days post administration is at least 25 mg/L.