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 stable adult cystic fibrosis volunteers recruited from up to 20 US sites with Pseudomonas aeruginosa airway colonization. The single dose of phage consists of a mixture of four anti-pseudomonal phages. Six sentinel participants will be sequentially enrolled with dose escalation of the phage mixture by one log₁₀ beginning with 4 × 10⁷ plaque-forming units in an unblinded stage 1. If no serious adverse events related to the study product are identified, the trial will pr

SUBMITTER: Tamma PD 

PROVIDER: S-EPMC9795609 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature