KB001-A in People with CF and Pseudomonas Aeruginosa
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to to evaluate the effect of KB001-A on time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo in people with CF who have chronic Pseudomonas aeruginosa (Pa) lung infection. Study participants will be randomized to receive 5 IV infusions of either study drug or placebo. Sputum specimens of blood, sputum, and urine will be taken during the trial as well as pulmonary lung function testing performed. This trial will last up to 22 weeks.
12 Years - 50 Years
40 - 100 Percent Predicted
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
Received anti-pseudomonal inhaled antibiotics for the equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit. Note: Chronic daily anti-pseudomonal inhaled antibiotic regimens are allowed.
Individuals with CF who are older than 50 years may participate if they have been treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory signs and symptoms (CF exacerbation) in the 12 months before the Screening Visit.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.