Cystic Fibrosis study: AchromoPhage
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?
This is an investigational mixture of viruses being studied as a potential treatment for lung infections in people with cystic fibrosis. It is designed to target and kill specific bacteria called Achromobacter.
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 study will see if the phage mixture AchromoPhage is safe and well tolerated in these patients and whether it affects lung function and bacteria.
- Who it's for
- Adults with cystic fibrosis who have chronic Achromobacter lung infection.
- What's involved
- Participants will receive the drug by inhalation, IV, or both, during clinic visits over three weeks. They will give blood, sputum, nasal, and oral samples, and complete breathing tests and quality‑of‑life questionnaires.
- Time commitment
- The study lasts 42 days, with clinic visits and sample collections during the first three weeks and follow‑up assessments afterward.
- 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
- 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), including transplant recipients
- Stable respiratory symptoms within 30 days prior to screening, with no change in CF maintenance medications (including cystic fibrosis transmembrane...
- Chronic Achromobacter respiratory infection, defined as isolation by culture of Achromobacter species from two or more respiratory, oral, and/or...
You likely can't join if
- 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.
- Hemoglobin \< 8 g/dL
See the full eligibility 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), including transplant recipients
- Stable respiratory symptoms within 30 days prior to screening, with no change in CF maintenance medications (including cystic fibrosis transmembrane conductance regulator (CFTR) modulators) within 30 days prior to...
- 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 within 12 months of the date of planned enrollment must be susceptible to at least 1 phage in AchromoPhage cocktail...
- 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 if activated for in-person phage administration 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.
- Serious medical illness requiring systemic treatment or hospitalization within 30 days prior to screening (unless medically stable and approved by the investigator).
- 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 investigator'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 is enrolling
- 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, but 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?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.