Research

Pseudomonas Aeruginosa Treatment Study

Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas aeruginosa Airway Infection in Young Patients with Cystic Fibrosis

Protocol Description

The primary goal of this study is to find the best, safest and shortest treatment against Pseudomonas aeruginosa (Pa) that will kill the Pa bacteria and provide the best outcomes for children with Cystic Fibrosis (CF). Participants will be randomized to one of two study therapies. All will receive TOBI® and half of the children in each group will receive either the antibiotic ciprofloxacin or a placebo. In one group, children will be treated once every 3 months (cycled therapy). In the other group, children will receive additional treatment only if their Pa culture is positive (culture-based therapy). Approximately 300 subjects at 60 CF Care Centers will take part in this study, including approximately 10 subjects from the Pediatric Clinical and Translational Research Center at Children’s Hospital of Pittsburgh of UPMC.

Eligibility Criteria

The study is focusing on children with cystic fibrosis between 1 and 12 years of age with new onset of Pseudomonas aeruginosa (Pa) in throat or sputum culture.
Boys: 1 to 12 years
Girls: 1 to 12 years

Requirements
Participation will be for 18 months. Patients will have an initial screening visit, and most other study visits will be held at the time of routine clinic visits. Participants will be asked to take assigned study medication, have blood tests, throat cultures, hearing tests, and keep a study diary during the course of the research.
Visits: 8
Duration: 18 months

Status: Open for Enrollment

Source of Support
National Heart Lung and Blood Institute
National Institute of Diabetes and Digestive and Kidney Diseases
Cystic Fibrosis Foundation

Additional Resources
Cystic Fibrosis