Faculty, Staff and Student Publications
Publication Date
12-28-2022
Journal
Trials
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 log
DISCUSSION: This trial will investigate the activity of phages in reducing P. aeruginosa colony counts and provide insights into the safety profile of phage therapy.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05453578. Registered on 12 July 2022.
Keywords
Adult, Humans, Cystic Fibrosis, Pseudomonas aeruginosa, Phage Therapy, Double-Blind Method, Quality of Life, Anti-Bacterial Agents, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Clinical Trials, Phase II as Topic, Clinical Trials, Phase I as Topic, Phage, Multidrug-resistant, Pseudomonas aeruginosa, Cystic fibrosis
Included in
Bioinformatics Commons, Biomedical Informatics Commons, Medical Sciences Commons, Oncology Commons
Comments
PMID: 36578069