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Background Antimicrobial susceptibility testing (AST) is a cornerstone of infection management. Cystic fibrosis (CF) treatment guidelines recommend AST to select antimicrobial treatments for CF airway infection but its utility in this setting has never been objectively demonstrated. Methods We conducted a systematic review of primary published articles designed to address two PICO (patient, intervention, comparator, outcome) questions: 1) “For individuals with CF, is clinical response to antimicrobial treatment of bacterial airways infection predictable from AST results available at treatment initiation?” and 2) “For individuals with CF, is clinical response to antimicrobial treatment of bacterial airways infection affected by the method used to guide antimicrobial selection?” Relationships between AST results and clinical response (changes in pulmonary function, weight, signs and symptoms of respiratory tract infection, and time to next event) were assessed for each article and results were compared across articles when possible. Results Twenty-five articles describing the results of 20 separate studies, most of which described Pseudomonas aeruginosa treatment, were identified. Thirteen studies described pulmonary exacerbation (PEx) treatment and seven described ‘maintenance’ of chronic bacterial airways infection. In only three of 16 studies addressing PICO question #1 was there a suggestion that baseline bacterial isolate antimicrobial susceptibility was associated with clinical response to treatment. None of the four studies addressing PICO question #2 suggested that antimicrobial selection methods influenced clinical outcomes. Conclusions There is little evidence that AST predicts the clinical outcome of CF antimicrobial treatment, suggesting a need for careful consideration of current AST use by the CF community.

BackgroundReducing nebulisation times for tobramycin solution for inhalation in cystic fibrosis (CF) may improve compliance.MethodsIn this single-dose, open-label, two-way crossover study, 13 subjects (7 CF, 6 healthy) were randomised to receive tobramycin via eFlow rapid or LC Plus jet nebuliser. Drug deposition in the lung using gamma scintigraphic imaging, nebulisation times, pharmacokinetics, and safety were evaluated.ResultsIn CF patients, whole-lung deposition was 40% less with the eFlow rapid compared with LC Plus nebulisers was (8.9±0.8%, and 15.1±6.0%, p>0.05). Nebulisation time was shorter with eFlow rapid compared to LC Plus (7.0min versus 20.0min, p

Many new therapies are emerging for the treatment of CF. In the last 2 years, six agents have been approved by the Food and Drug Administration (FDA) and four agents have given an opinion in favor of granting a marketing authorization by the European Medicines Agency (EMA) representing dramatic results from decades of investment in basic and clinical science. In this month's journal, Assael and colleagues present data from a phase 3 open-label, randomized, parallel-group, active-comparator non-inferiority trial comparing aztreonam for inhalation solution (AZLI) and inhaled tobramycin nebulizer solution (TNS)...

73 Real world evidence on inhaled tobramycin use in CF patients: analysis of the RAMQ data (Canada) J. Lachaine1, M.-E. Lapierre2, C. Beauchemin2, G. Angyalosi3, M.-M. Balp3, F. Calado3, L. Debonnett4, J. Desforges5, A. Sagkriotis3. 1University of Montreal, Faculty of Pharmacy, Montreal, Canada; 2University of Montreal, Montreal, Canada; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Pharmaceuticals Corporation, New York City, United States; 5Novartis Pharmaceuticals Canada Inc., Dorval, Canada

73 Real world evidence on inhaled tobramycin use in CF patients: analysis of the RAMQ data (Canada) J. Lachaine1, M.-E. Lapierre2, C. Beauchemin2, G. Angyalosi3, M.-M. Balp3, F. Calado3, L. Debonnett4, J. Desforges5, A. Sagkriotis3. 1University of Montreal, Faculty of Pharmacy, Montreal, Canada; 2University of Montreal, Montreal, Canada; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Pharmaceuticals Corporation, New York City, United States; 5Novartis Pharmaceuticals Canada Inc., Dorval, Canada

year. Data are presented as Median (Interquartile Range) and 2-tailed, Wilcoxon signed-rank tests were used to compare parameters. Results: 11 patients [Median Age: 30 (19–61)] years, had 6-month data available. All patients tolerated the treatment well. The results are shown in the table below. Conclusions: Our experience and this data suggests a significant clinical benefit in the short term in a select group of acutely deteriorating adult CF patients and we continue to monitor its effects over the longer term.

Objectives Allergic Bronchopulmonary Aspergillosis syndrome (ABPAs) occurs in 10 to 15% of the CF patients. We intend to study facilitators and consequences of ABPAs in P. aeruginosa (Ps) colonized CF patients. Methods Sixty four ABPAs and Ps colonized patients matched for age and gender were compared to 128 controls. FEV1, FVC, infectious exacerbations and BMI were studied 10 years before until 10 years after the index year. Results On the index year no differences were found for BMI, FVC and FEV1. Patients with ABPAs have a higher prevalence of CFRD and significantly more were on treatment with inhaled corticosteroids, RhDnase, azithromycin and inhaled tobramycin. Cumulative values (FEV1, FVC, days of IV antibiotics) over the period before the index year were similar, over the 10 years period after the index year significantly lower values for FEV1 (p Significantly more patients with ABPAs had at least one positive culture for A. fumigatus (p Conclusion In chronic Ps colonized CF patients lower lung function values are not a facilitating factor for ABPAs. Inhaled corticosteroids, RhDnase, azithromycin and inhaled tobramycin were significantly more prevalent in the ABPA group. ABPAs patients needed significantly more antibiotics, in contrast with controls, after than before the index year.

Background Several guidelines on infection control and treatment of infection exist for cystic fibrosis (CF) caregivers, although the extent of implementation is variable. Methods Adherence to European Consensus Guidelines for CF was studied by sending surveys to named healthcare professionals in 487 European CF centres/units. Qualitative data analysis was performed. Results A total of 177/547 (32%) surveys were returned. Infection control policies were implemented by most (77%) respondents. Separation of patients with Burkholderia cepacia was more common in adults (95%) than children (9%), and was implemented by 53% of respondents for Pseudomonas aeruginosa . Nebulised colistin plus oral ciprofloxacin was the most common (43%) therapy for P. aeruginosa infection. First infections of P. aeruginosa were usually treated with inhaled tobramycin; 41% of repondents did not intervene until lung function deteriorated. Most exacerbations were treated for less than the recommended period. Conclusions European Consensus Guidelines are widely adhered to. Areas for improvement include: initiating therapy for exacerbations early, separating infected patients and optimising duration of antibiotic therapy.

BackgroundInhaled tobramycin therapy has been shown to be efficacious in clinical trials for the eradication of initial Pseudomonas aeruginosa infection in children with cystic fibrosis (CF). However, the effectiveness of different regimens in eradicating P. aeruginosa and preventing the development of chronic infection in actual clinical settings has yet to be determined.MethodsThis was an observational study of children (