Analysis of P. aeruginosa infection in patients
AssigneeStc.Unm
InventorsGraham Timmins, Vojo P. Deretic
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Abstract
The present invention relates to methods for detecting P aeruginosa infection and bacterial burden in the lungs of patients who are at risk for P. aeruginosa infections, especially including patients with Cystic Fibrosis (CF). The present method provides numerous tests (breath, blood, urine) which are readily administered to a patient that will sensitively and specifically detect the presence and extent of lung infection P. aeruginosa (both mucoid and non-mucoid), and allow monitoring of bacterial load as a parameter in monitoring treatment.
Claims42
A method for diagnosing the presence of Pseudomonas aeruginosa in the lungs or other tissues of a patient or subject, including the steps of:
- (a) administering an effective amount of at least one isotopically labeled active agent selected from the group consisting of a nitrate salt, a nitrite salt, nitric oxide (NO), a nitric oxide precursor compound, urea and glycine or their pharmaceutically acceptable salts to the subject, said active compound being acted upon by P. aeruginosa to form an isotopically labeled cleavage product or metabolite;
- and
- (b) collecting breath, urine, whole blood, plasma or serum samples from the subject;
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- (c) analyzing said samples to determine a concentration or concentrations of said cleavage product(s) or metabolite(s), said concentration(s) indicating the presence or absence of P. aeruginosa including optionally, the presence or absence of mucoid phenotype P. aeruginosa, in the lungs or other tissues of said patient.
A single dose composition adapted for pulmonary administration to a subject to be diagnosed for the existence or absence of mucoid P. aeruginosa in the lungs of a patient, said composition consisting essentially of a diagnostic effective amount of glycine and urea or pharmaceutically acceptable salts thereof, optionally in combination with at least one agent selected from the group consisting of a nitrate salt, a nitrite salt, nitric oxide gas and a nitric oxide precursor compound or its pharmaceutically acceptable salt, in combination with a pharmaceutically acceptable excipient, a propellant and optionally, a solvent and a dispersant, said composition being further adapted for single use only.
A single dose composition adapted for oral administration to a subject to be diagnosed for the existence or absence of mucoid P. aeruginosa in the lungs of said subject, said composition consisting essentially of a diagnostic effective amount of glycine and urea or pharmaceutically acceptable salts thereof, optionally in combination with at least one agent selected from the group consisting of a nitrate salt, a nitrite salt, and a nitric oxide precursor compound or its pharmaceutically acceptable salt, in combination with a pharmaceutically acceptable carrier, additive or excipient and optionally, an effective amount of a urease inhibitor.
Use of effective amounts of glycine and/or urea in the manufacture of a composition for the diagnosis of P. Aeruginosa in a subject.
Dependencies are inferred from the claim text.