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New treatment option for Cystic Fibrosis (CF)
Official title Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
ClinicalTrials.gov ID: NCT07275905
What this study is testing
What is AchromoPhage?
AchromoPhage is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cystic fibrosis (cf).
Also referred to as Phage, Bacteriophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Currently breastfeeding, pregnant, or planning to become pregnant within 6 months.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.