Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection (NCT07275905)
A Phase 1, Open-label, Randomized, Pilot and Feasibility Trial to Evaluate the Safety and Tolerability of the Achromobacter-targeting Bacteriophage Cocktail, AchromoPhage, Among Persons With Cystic Fibrosis and Chronic Achromobacter Lung Infections: The AchromoPhage Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if a new treatment called AchromoPhage is safe and well tolerated in adults with cystic fibrosis (CF) who have long-term lung infections caused by Achromobacter bacteria. AchromoPhage is a mixture of four naturally occurring viruses, called phages, that are designed to target and kill Achromobacter. This study will include 12 participants. People will be randomly assigned to one of three groups to receive AchromoPhage in different ways: by inhalation only, by intravenous (IV) infusion only, or by inhalation followed by IV infusion. Participants will: * Receive the study drug during clinic visits over a period of three weeks. * Provide blood, sputum, nasal, and oral samples so researchers can measure how the phages move through the body, how long they stay, and whether the body develops a response against them. * Complete breathing tests and quality-of-life questionnaires. The main question this study will answer is whether AchromoPhage causes any serious or treatment-limiting side effects in the first 42 days after dosing. Researchers will also look at changes in lung function, quality of life, phage levels in the body, and how the treatment affects Achromobacter and other bacteria in the lungs. The study is being run at the University of Pittsburgh (Pittsburgh, PA) and the University of California San Diego (San Diego, CA).
Who can join: Review the eligibility criteria below.
Location: University of California San Diego (UCSD) โ San Diego, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- University of California San Diego (UCSD) โ San Diego, California
- University of Pittsburgh โ Pittsburgh, Pennsylvania
๐ Contact the Study Coordinator
Phone: (412) 368-6380
Email: BRB415@pitt.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis (CF)
- Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta โ Denver, Colorado
- Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care โ Santa Ana, California
- Rethinking Early Airway Clearence Therapies โ Birmingham, Alabama
- MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . โ Toronto, Ontario
- Nutrition Supplement for Cystic Fibrosis โ Columbus, Ohio
- Study to Enable New Diagnostics for Pulmonary Microbes in People With CF โ La Jolla, California
Explore by condition: All Cystic Fibrosis (CF) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.