A Proof of Concept Study to Detect Urease Producing Bacteria in Lungs Using Aerosolized 13C-Urea.
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-a...
| Publicado en: | Pediatric Allergy, Immunology & Pulmonology Vol. 29; no. 2; pp. 68 - 74 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Mary Ann Liebert, Inc.
Jun2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=116193419&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 116193419 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 2151321X B9EX jtl: Pediatric Allergy, Immunology & Pulmonology issn: 2151321X maglogo: N pubinfo: dt: Jun2016 vid: 29 iid: 2 pid: 1365 pub: Mary Ann Liebert, Inc. place: New Rochelle, New York artinfo: ui: 116193419 116193419 116193419 10.1089/ped.2015.0619 116193419 ppf: 68 ppct: 6 formats: tig: atl: A Proof of Concept Study to Detect Urease Producing Bacteria in Lungs Using Aerosolized 13C-Urea. aug: au: Raissy, Hengameh H. Timmins, Graham Davies, Lea Heynekamp, Theresa Harkins, Michelle Sharp, Zachary D. Kelly, H. William affil: Department of Pediatrics, School of Medicine, University of New Mexico, Albuquerque, New Mexico. sug: subj: Helicobacter Pylori Cystic Fibrosis Drug Therapy Patents Cystic Fibrosis Physical Examination Urea Urease Safety Study Design Prospective Studies Data Analysis Child, Preschool Sensitivity and Specificity Adult Child, Preschool: 2-5 years Adult: 19-44 years ab: 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 jet nebulizer, followed by serial spirometry (10 min and 30 min post inhalation) and collection of exhaled breath at 5, 10, and 15 min post inhalation. There was no clinical significant change in any of the spirometry values compared to baseline in healthy participants and CF patients. Mean of 13CO2/12CO2 delta over baseline (DOB) values in CF participants at 5, 10, and 15 min post inhalation was as follows: 20 mg dose 4‰ (2.2‰-4.9‰), 1‰ (1.0‰-1.4‰), and 1‰ (0.4‰-1.5‰); 50 mg dose: 10‰ (6.2‰-14.5‰), 3‰ (2.1‰-4.3‰), and 1.5‰ (0.6‰-2.3‰). Inhaled 13C-urea for detection of urease producing bacteria was safe, and preliminary data suggest that 13CO2/12CO2 DOB values may be higher in CF patients with P. aeruginosa at 5-10 min after inhalation of 13C-urea. A future direction is to investigate use of inhaled 13C-urea in young children who have difficulty producing sputum for culturing. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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