CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa - Phase 1|Phase 2 - Not yet recruiting

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment

Participants

Bacterial Disease Carrier|Cystic Fibrosis - 18 Years to 99 Years   (Adult, Older Adult)

Interventions

Other: Placebo|Biological: WRAIR_PAM-CF1

Outcome measures

Change from baseline in log10 P. aeruginosa total colony counts in quantitative sputum cultures|Desirability of Outcome Ranking (DOOR)|Number of grade 2 or higher treatment-emergent Adverse Events

Keywords: Phage therapy; Anti-bacterial agents; pharmacological_intervention; Bacterial Infections; Infection; Inhalation OR nebulised; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections;