Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGhady Haidar
About this trial
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).
Eligibility criteria
Qualifiers
Adults of any gender, age 18 years or greater at the time of enrollment.
Weight of 40 kg or greater.
Diagnosed with cystic fibrosis (CF).
Stable respiratory symptoms within 30 days prior to screening.
Disqualifiers
Serious medical illness requiring systemic treatment or hospitalization within 30 days prior to screening (unless medically stable and approved by the PI).
Acute pulmonary exacerbation requiring systemic antibiotics within 30 days prior to screening.
Acute respiratory illness, including viral infection, within 30 days prior to screening.
Grade 3 or higher alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at or within 30 days prior to screening, defined as ALT or AST values >5.0 x upper limit of normal (ULN).
Trial design
Treatments tested in this trial
- AchromoPhage
Treatment groups
12 Participants
are divided into 3 treatment groupsSponsors and collaborators
Ghady Haidar
Lead sponsor
University of Pittsburgh
Sponsor institution
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov