Inclusion criteria | Exclusion criteria |
---|---|
● Male or female ≥12 years of age | ● An acute upper or lower respiratory infection, pulmonary exacerbation, or change in routine therapy (including antibiotics) for pulmonary disease within 42 days of the Day 1 visit (2 weeks prior to screening visit) |
● Confirmed diagnosis of CF based on the following criteria: | ● Individuals on continuous inhaled antibiotics without interruption who are not willing to substitute vancomycin or placebo for their scheduled inhaled antibiotic during days 0–28 of the study |
● 1. Positive sweat chloride >60 mEq/L (by pilocarpine iontophoresis) and/or | |
● 2. A genotype with two identifiable mutations consistent with CF or abnormal nasal potential difference, and | |
● 3. One or more clinical features consistent with the CF phenotype | |
● Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study | ● Use of oral or inhaled anti-MRSA drugs within two weeks of the screening visit |
● Two positive MRSA respiratory cultures in the last 2 years at least 6 months apart, plus a positive MRSA respiratory culture at the screening visit and run-in (Day −14) visit | ● History of intolerance to inhaled vancomycin or inhaled albuterol |
● At least 50% of respiratory cultures from the time of the first MRSA culture (in the last 2 years) have been positive for MRSA | ● History of intolerance to rifampin or both trimethorpim/sulfamethoxazole (TMP/SMX) and doxycycline |
● FEV1 > 30% of predicted normal for age, gender, and height at screening | ● Resistance to rifampin or both TMP/SMX and doxycycline at screening |
● Females of childbearing potential must agree to practice an acceptable method of birth control (in the opinion of the investigator), including abstinencea. Female patients who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before study dosing | ● Resistance to vancomycin at screening |
● Abnormal renal function, defined as creatinine clearance <50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation in children, at screening | |
● Abnormal liver function, defined as ≥3x upper limit of normal, of serum aspartate transaminase or serum alanine transaminase, or known cirrhosis at the time of screening | |
● Serum hematology or chemistry screening results which in the judgment of the investigator would interfere with completion of the study | |
● History of or listed for solid organ or hematological transplantation | |
● History of sputum culture with non-tuberculous Mycobacteria in the last 6 months | |
● History of sputum culture with Burkholderia Cepacia in the last year | |
● Planned continuous use of soft contact lenses while taking rifampin and no access to glasses | |
● Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day | |
● Taking voriconazole and unable to discontinue its use from run-in visit to Day 29 end-of-treatment visit | |
● Administration of any investigational drug or device within 28 days of screening or within 6 half-lives of the investigational drug (whichever is longer) | |
● Patients on inhaled antibiotics must have been on the same regimen for the 4 months prior to screening | |
● Female patients of childbearing potential who are pregnant or lactating, or plan on becoming pregnant | |
● Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol |