Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)

Exclusion Criteria

• •Sputum culture negative for P. aeruginosa or density less than 10E5 CFU/gm at screening.
• •Sputum culture positive for B. cepacia at screening.
• •Presence of P. aeruginosa in sputum with off-scale resistance to all antibiotics by either method of susceptibility testing at screening. (changed from multiply-resistant P. aeruginosa by protocol amendment)
• •History of B. cepacia positive respiratory culture within 24 months prior to screening.
• •Hospitalization or treatment for a pulmonary exacerbation within 2 months prior to screening.
• •Administration of parenteral anti-pseudomonal antibiotics within 2 months prior to screening.
• •Treatment with oral or inhaled anti-pseudomonal antibiotics, or azithromycin or other macrolides within 14 days prior to screening.
• •History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option.
• •History of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option.
• •History of abnormal renal function (serum creatinine \> 1.5 x upper limit of normal) within one year of enrollment.
• •History of abnormal liver function tests (\> 2.5 x upper limit of normal) within one year of enrollment.
• •Clinically documented hearing loss that precludes treatment with aminoglycosides.
• •Post lung transplantation.
• •Positive pregnancy test or female who is lactating or is not practicing an acceptable method of birth control.
• •Presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data.
• •Administration of any investigational agent within 30 days prior to screening.