https://pittplusme.org/study/cysticfibrosis
AchromoPhage Clinical Trial
STUDY BASICS
Do you have cystic fibrosis? You may be eligible to help advance new treatments for cystic fibrosis and chronic Achromobacter infections. This research study is to evaluate the safety and tolerability of AchromoPhage in adults with cystic fibrosis and chronic Achromobacter infection. Compensation is provided.
STUDY PURPOSE
The purpose of this study is to evaluate the safety and tolerability of AchromoPhage in adults with cystic fibrosis and chronic Achromobacter infection. Achromophage is a cocktail of four bacteriophages designed to target Achromobacter.
COULD THIS STUDY BE RIGHT FOR YOU?
- Adults age 18 or older with cystic fibrosis
- Chronic Achromobacter lung infection
- Stable respiratory symptoms
- FEV1 ≥ 40% predicted
WHAT PARTICIPANTS CAN EXPECT
This study requires 7 study visits. Study visits 1, 2, and 3 will last about 4 hours. Study visits 4, 5, 6, and 7 will last approximately 1 hour. Study visits 1, 2, and 3, you will be randomly assigned to receive IV, inhaled, or IV and inhaled AchromoPhage. Additionally, this study will be asking people to complete a series of questionnaires about their quality of life, a study diary, and spirometry testing, and will collect blood, urine, nasal swabs, and throat swabs.
IRB: STUDY25050049
- 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 A
MEET THE RESEARCHER
Ghady Haidar
Ghady Haidar MD is an Assistant Professor of Medicine in the Division of Infectious Diseases at the University of Pittsburgh, and a Transplant ID physician at UPMC. He is the Program Director for the Transplant ID Fellowship, and Director of Research for the Hematological Malignancy ID Program. As a physician-investigator, he is actively involved in clinical and translational research with a focus on infectious in immunocompromised patients, including refractory bacterial infections and SARS-CoV-2. He is the PI for an NIH-funded K23 award evaluating the changes in the microbiome after organ transplantation, and is also a PI on several industry-funded grants.