NCT07275905 · Ghady Haidar
Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
What this study is about
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.
View original scientific description
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).
Interventions
BIOLOGICAL
AchromoPhage
AchromoPhage is a cocktail of four genetically distinct, obligately lytic bacteriophages (phiACH01, phiACH04, phiACH06, phiACH07) with in vitro activity against \>75% of a panel of 17 genetically diverse Achromobacter isolates from persons with cystic fibrosis. In this study, AchromoPhage will be administered by inhaled, intravenous, or sequential inhaled + intravenous routes with weekly dose escalation. Each participant will receive three weekly administrations, with escalating total doses of 4×10⁷ PFU, 4×10⁸ PFU, and 4×10⁹ PFU per route (double the total dose in the combination arm).
Primary outcome measures
Incidence of treatment-related Grade ≥4 adverse events or treatment-limiting toxicities
Time frame: 42 Days
Incidence of treatment-related Grade 4 or higher adverse events or any treatment-limiting toxicities, assessed overall and by treatment group, from the first dose through Day 42. Severity grading will follow the protocol-specified adverse event definitions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Chronic Achromobacter respiratory infection, defined as isolation by culture of Achromobacter species from two or more respiratory, oral, and/or nasopharyngeal samples provided by the participant within 24 months before the date of pre-screening.
- At least one Achromobacter isolate cultured from a respiratory, oral, and/or nasopharyngeal sample provided by the participant no more than 60 days before the date of planned enrollment must be susceptible to at least 1 phage in AchromoPhage cocktail using study assays.
- FEV1 ≥ (greater than or equal to) 40% of predicted at time of screening
- Ability and willingness to provide informed consent or, if applicable, the ability and willingness of legal guardian/representative to provide informed consent.
- Willingness to comply with study procedures.
- Ability to travel to the University of Pittsburgh or the University of California San Diego for phage administration and in-person visits.
- Agreement not to enroll in other bacteriophage studies or receive bacteriophages for clinical care during the study, except in life-saving situations.
- For females of reproductive potential, a negative urine pregnancy test at the time of consent (before randomization and dosing).
- Willingness to use highly effective contraception or other preventive measures to avoid conception during the study and for 6 months after the last phage dose. Note, criteria 5 and 6 are the microbiologic criteria.
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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).
- Currently breastfeeding, pregnant, or planning to become pregnant within 6 months.
- Hemoglobin \< 8 g/dL
- Absolute neutrophil count \< 1000 cells/uL
- Intolerance to inhaled therapies.
- Known allergy or sensitivity to components of the AchromoPhage cocktail.
- Any other condition that, in the PI's opinion, would interfere with the conduct of the study or would not be in the participant's best interest.
Where
- San Diego, California
- Pittsburgh, Pennsylvania
Collaborators
Cystic Fibrosis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations