An open-label study to evaluate the safety and tolerability of inhaled Teicoplanin in the treatment of Staphylococcus aureus (including mrsa) infections in cystic fibrosis patients

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• Patients with chronic Pseudomonas aeruginosa and Bulkholderia cepacia infections will be excluded from the study because it is known that these pathogens cause progressive loss of lung function and requires the administration of inhaled antibiotics. Patients with colonization by others Gram – are instead elegible
• Patients with known episodes of bronchoconstriction after drug inhalation.
• Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator's opinion, would compromise the safety of the subject or the quality of the study data.
• Ongoing or prior participation in an investigational drug study within 28 days of the Screening Visit. A washout period of 5 terminal half-lives of the previous investigational study drug, or 28 days, whichever is longer, must elapse before the Screening Visit.
• Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for one months later.
• Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.