Compositions and kits for diagnosing infections

Abstract

The present invention is directed to the use of isotopically labeled citrulline for diagnosing the presence or absence of a bacterial infection in the lungs of a patient.

1 - 17 . (canceled) 
     
     
         18 . A composition adapted for pulmonary administration to a patient to be diagnosed for the existence or absence of a bacterial lung infection, said composition consisting essentially of a diagnostic effective amount of isotopically labeled citrulline or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable excipient, a propellant and optionally, a solvent and a dispersant, said composition being further adapted for single use. 
     
     
         19 . The composition according to  claim 18  wherein said isotopically labeled citrulline, 1 or pharmaceutically acceptable salt thereof is present in an amount ranging from about 0.25 mg to about 10 mg. 
     
     
         20 . The composition according to  claim 18  wherein said composition is an aerosol. 
     
     
         21 . The composition according to  claim 18  adapted for delivery through an inhaler. 
     
     
         22 . The composition according to  claim 18  wherein said solvent is a mixture of water and ethanol and said propellant is a CFC substitute fluorinated hydrocarbon. 
     
     
         23 . A composition adapted for oral administration to a patient to be diagnosed for the existence or absence of a bacterial lung infection, said composition consisting essentially of a diagnostic effective amount of isotopically labeled citrulline or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable carrier, additive, or excipient. 
     
     
         24 . The composition according to  claim 23  having an enteric coating. 
     
     
         25 . The composition according to  claim 23  wherein said isotopically labeled citrulline or pharmaceutically acceptable salt thereof is present in an amount ranging from about 0.5 mg to about 100 mg. 
     
     
         26 . A unit dosage form kit comprising a single use container and a diagnostically effective amount of isotopically labeled citrulline, or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable carrier, additive, or excipient. 
     
     
         27 . A kit comprising at least one unit dosage of isotopically labeled citrulline or a pharmaceutically acceptable salt thereof, and at least one device for the delivery of the isotopically labeled citrulline to a patient or at least one breath collection device, or a combination of such devices. 
     
     
         28 . The kit of  claim 26  comprising a plurality of unit dosages of isotopically labeled citrulline, and further comprising instructions for assaying the presence or absence of a bacterial lung infection in a patient. 
     
     
         29 . The kit according to  claim 27  wherein the device for the delivery of the isotopically labeled citrulline is an inhaler. 
     
     
         30 . The kit according to  claim 26 , wherein the breath collection device is a bag or a vial. 
     
     
         31 . Isotopically labeled citrulline, or a pharmaceutically acceptable salt thereof, comprising  13 C,  14 C,  17 O,  18 O,  15 N, or mixture thereof, wherein the  13 C,  14 C,  17 O,  18 O, or  15 N is present in an amount greater than natural abundance. 
     
     
         32 . The isotopically labeled citrulline of  claim 31 , wherein the citrulline is