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20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa

Recruiting

We are looking at a new intravenous drug, Bacteriophage, to treat Pseudomonas Aeruginosa in people at least 18 years of age who have cystic fibrosis. The drug is given one time and different doses will be evaluated to see if they work and to look at side effects.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Cystic Fibrosis (CF) diagnosis based on clinical symptoms and confirmed by either an abnormal sweat chloride test or CFTR gene variations
• P. aeruginosa isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
Exclusion Criteria:

• body weight less than 30 kg
• Forced Expiratory Volume 1 second less than 20% of predicted value
• women who are pregnant, planning to become pregnant during the study, or breastfeeding
• anticipate change chronic antibiotic regimens during the study

Other: Placebo, Biological: WRAIR-PAM-CF1

Respiratory System, Rare Diseases

CF, Cystic Fibrosis, P. aeruginosa, Pseudomonas Aeruginosa

Melissa Rhodes - frak0001@umn.edu
Joanne Billings
PHASE1
SITE00001310
See this study on ClinicalTrials.gov

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