Safety and microbiological activity of phage therapy in persons with cystic fibrosis colonized with Pseudomonas aeruginosa: study protocol for a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial

Safety and microbiological activity of phage therapy in persons with cystic fibrosis colonized with Pseudomonas aeruginosa: study protocol for a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial

Abstract Background Bacteriophages (phages) are a promising anti-infective option for human disease. Major gaps remain in understanding their potential utility. Methods This is a randomized, placebo-controlled, double-blind study of a single dose of intravenous phage in approximately 72 clinically s...

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Bibliographic Details
Main Authors: Pranita D. Tamma, Maria Souli, Michael Billard, Joseph Campbell, Douglas Conrad, Damon W. Ellison, Beth Evans, Scott R. Evans, Kerryl E. Greenwood-Quaintance, Andrey A. Filippov, Holly S. Geres, Toshimitsu Hamasaki, Lauren Komarow, Mikeljon P. Nikolich, Thomas P. Lodise, Seema U. Nayak, Carmelle Norice-Tra, Robin Patel, David Pride, Janie Russell, Daria Van Tyne, Henry F. Chambers, Vance G. FowlerJr, Robert T. Schooley, for the Antibacterial Resistance Leadership Group
Format: Article
Language:English
Published: BMC 2022-12-01
Series:Trials
Subjects:
Phage
Multidrug-resistant
Pseudomonas aeruginosa
Cystic fibrosis
Online Access:https://doi.org/10.1186/s13063-022-07047-5

Internet

https://doi.org/10.1186/s13063-022-07047-5

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