Bacterial Disease Carrier clinical trials at UCSD
1 in progress, 0 open to eligible people
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
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This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old and diagnosed with Cystic Fibrosis (CF), and residing in the United States. This clinical trial is designed to assess the safety and microbiologic activity of bacteriophage product WRAIR_PAM-CF1, directed at Pseudomonas aeruginosa in clinically stable CF individuals. WRAIR_PAM-CF1 is a 4 component anti-pseudomonal bacteriophage containing between >/= 4 x 107 and >/= 4 x 109 Plaque Forming Units (PFU) in the target dose. Enrollment will occur at up to 20 clinical research sites in the United States. In stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 107 PFU, 4 x 108 PFU, and 4 x 109 PFU; total of 6 sentinel subjects), followed by a 96-hour observation period. Stage 2a will proceed if no serious adverse events (SAEs) related to the study product occur during the observation period of stage 1; 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 107 PFU, 4 x 108 PFU, and 4 x 109 PFU) in a 1:1:1:1 allocation. An interim analysis after all subjects have completed follow up visit 5 on Day 30 will be performed to select an IV bacteriophage dose with the most favorable safety and microbiologic activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose.
La Jolla, California and other locations