The Antimicrobial Drugs Advisory Committee (ADAC) voted 12-3, with 1 abstention, against supporting a posed question of whether applicant Aradigm Corporation provided substantial evidence for the safety and efficacy of inhaled ciprofloxacin dispersion (Linhaliq), in delaying the time to first exacerbation after starting treatment in NCFBE patients with the chronic lung infection. The vote of recommendation came 2 weeks prior to the therapy’s Prescription Drug User Fee Act (PDUFA) action date of January 26. While the FDA will make its own decision to Aradigm’s application, it takes the committee’s advice into consideration. Ciprofloxacin dispersion’s candidacy for NCFBE patients with chronic lung infections is based on data from 3 clinical trials. The 2 phase 3 studies included in Aradigm’s application (ORBIT-3, ORBIT-4) were 48-week, multinational, randomized 2:1 double-blind trials with a placebo-controlled population. The primary endpoint in both trials was an increase in the median time to first mild, moderate or severe pulmonary exacerbation (PE). In ORBIT-3, the median time to first mild, moderate or severe PE was 221 days in the once-daily ciprofloxacin treatment group, versus 136 days in the placebo group, a similar rate to that of ORBIT-4 (230 days versus 163 days, respectively) but not statistically significant (0.3125). Centre of Biological Engineering, Institute for Biotechnology and Bioengineering (IBB), University of Minho, Campus de Gualtar, 4710–057 Braga, Portugal Received ; Accepted 21 June 2012Academic Editors: L. The recovery ability of the biofilm-growing bacteria subjected to intermittent antibiotic pressure (ciprofloxacin (CIP) and gentamicin (GM)), as well as the development of resistance towards antibiotics and benzalkonium chloride (BC), were also determined. aeruginosa (PA) adhesion, biofilm formation and sensitivity to antibiotics. This work aims at characterizing endoscope biofilm-isolated (PAI) and reference strain P. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The capacity of both strains to develop biofilms was greatly impaired in the presence of CIP and GM. Sanitization was not complete allowing biofilm recovery after the intermittent cycles of antibiotic pressure. The environmental pressure exerted by CIP and GM did not develop P.
) depletion mainly due to polymorphonuclear leucocyte activity. Whilst the exact mechanisms affecting antibiotic effectiveness on biofilms remain unclear, accumulating evidence suggests that the efficacy of several bactericidal antibiotics such as ciprofloxacin is enhanced by stimulation of the aerobic respiration of pathogens, and that lack of O, 2.8 bar), enhancing the diffusive supply for aerobic respiration during ciprofloxacin treatment. © 2002, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Pseudomonas aeruginosa has become an important cause of gram-negative infection, especially in patients with compromised host defense mechanisms. It is the most common pathogen isolated from patients who have been hospitalized longer than 1 week, and it is a frequent cause of nosocomial infections. Ciprofloxacin is an antibiotic used to treat a number of bacterial infections. This includes bone. four-fold improvement in activity against the important Gram-negative pathogen Pseudomonas aeruginosa, making ciprofloxacin one of the most.