A Proof of Concept Study to Detect Urease Producing Bacteria in Lungs Using Aerosolized ¹³C-Urea.

ABSTRACT: This is a "proof of concept" study to determine whether inhalation of ¹³C-urea can be safely used to detect the presence of urease producing bacteria in the airways of patients with cystic fibrosis (CF) by detecting ¹³CO₂ in breath. This was a prospective, 2-part, open label, single-center, single-arm, single-administration, dose-escalation investigational device exemption trial. First, the safety of 20 and 50 mg inhaled ¹³C-urea was evaluated in 6 healthy adult participants. Then, 3 adult CF participants colonized with Pseudomonas aeruginosa were enrolled for each dose of inhaled ¹³C-urea. The safety of inhaled ¹³C-urea was assessed by spirometry and physical examination. ¹³C-urea was administered using a

SUBMITTER: Raissy HH 

PROVIDER: S-EPMC4926200 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature