AchromoPhage for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AchromoPhage to determine its safety for adults with cystic fibrosis who have long-term lung infections caused by Achromobacter bacteria. AchromoPhage uses a mix of viruses, known as phages, to target and kill the bacteria. Participants will receive the treatment through one of three methods: inhalation, intravenous infusion, or both. Ideal candidates are adults with cystic fibrosis who have ongoing Achromobacter lung infections confirmed by tests. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AchromoPhage is being tested for safety in treating cystic fibrosis patients with lung infections caused by Achromobacter bacteria. AchromoPhage uses phages, natural viruses that specifically target certain bacteria. Studies have found that phage therapies are generally safe for humans, with few serious side effects.
For the inhaled form of AchromoPhage, similar treatments have been safely used in cystic fibrosis patients to reduce lung infections, with common side effects being mild, such as throat irritation. When administered through an IV, research suggests AchromoPhage can be given safely, though monitoring for any unexpected reactions is important.
Using both inhaled and IV methods together might slightly increase the chances of mild side effects, but serious problems are rare based on past phage studies. Current research aims to ensure these side effects remain minor and manageable.
Overall, while this study is in its early stages, past research on phage treatments suggests that AchromoPhage could be a safe option for those with cystic fibrosis who have difficult lung infections. Participants in the study will be closely monitored to quickly catch any side effects.12345Why are researchers excited about this trial's treatment?
Researchers are excited about AchromoPhage for cystic fibrosis because it introduces a novel approach to tackling bacterial infections in the lungs. Unlike conventional antibiotics, which often struggle with resistant bacteria, AchromoPhage uses bacteriophages, viruses that specifically target and destroy bacteria. This targeted mechanism could potentially reduce the risk of side effects and antibiotic resistance. Additionally, AchromoPhage offers flexible delivery methods: it can be inhaled directly into the lungs or administered intravenously, allowing for tailored treatment approaches. These distinctive features could significantly enhance the management of lung infections in cystic fibrosis patients.
What evidence suggests that AchromoPhage might be an effective treatment for cystic fibrosis?
Research shows that bacteriophages, such as AchromoPhage, could offer a promising treatment for lung infections caused by Achromobacter in people with cystic fibrosis. These phages are viruses that specifically target and kill harmful bacteria. Studies on similar inhaled treatments have demonstrated improvements in lung function and reductions in infections among cystic fibrosis patients. In this trial, participants will receive AchromoPhage through different methods: some via inhalation, others intravenously, and some with a combination of both. This approach aims to determine if combining inhaled and intravenous (IV) methods might enhance effectiveness by helping the phages reach more infected areas. Although AchromoPhage remains under study, it is designed to tackle persistent infections that resist regular antibiotics.16789
Who Is on the Research Team?
Ghady Haidar, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults with cystic fibrosis who have chronic lung infections caused by Achromobacter bacteria. Participants will be divided into three groups to receive a new treatment called AchromoPhage through inhalation, IV infusion, or both.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AchromoPhage via inhalation, intravenous, or both, with escalating doses over three weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of lung function and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- AchromoPhage
Trial Overview
AchromoPhage, a mix of viruses targeting Achromobacter, is being tested for safety and effectiveness in CF patients with chronic lung infections. The study involves clinic visits over three weeks for dosing and monitoring through samples and questionnaires.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive a single weekly administration of AchromoPhage via the intravenous route. Each weekly administration consists of escalating intravenous doses of the cocktail. * Day 0 (visit 1, 1st week): 4×10⁷ total PFU * Day 7 (visit 2, 2nd week): 4×10⁸ total PFU * Day 14 (visit 3, 3rd week): 4×10⁹ total PFU
Participants will receive a single weekly administration of AchromoPhage via the inhaled route for a total of three administrations. Each weekly administration consists of escalating inhaled doses of the cocktail: * Day 0 (visit 1, 1st week): 4×10⁷ total PFU * Day 7 (visit 2, 2nd week): 4×10⁸ total PFU * Day 14 (visit 3, 3rd week): 4×10⁹ total PFU
Participants will receive a single weekly administration of AchromoPhage, which will consist of an inhaled dose followed by an intravenous dose given during the same study visit, with a 60-minute wait between doses. Weekly dose escalation will apply to each route, resulting in a total dose that is double that of the single route arms, as follows: * Day 0 (visit 1, 1st week): 8×10⁷ totalPFU \[i.e. 4×10⁷ total PFU inhaled, followed by a 60-minute wait, then 4×10⁷ total PFU intravenous\] * Day 7 (visit 2, 2nd week):8×10⁸ total PFU \[i.e. 4×10⁸ total PFU inhaled, followed by a 60-minute wait, then 4×10⁸ total PFU intravenous\] * Day 14 (visit 3, 3rd week): 8×10⁹ total PFU \[i.e. 4×10⁹ total PFU inhaled, followed by a 60-minute wait, then 4×10⁹ total PFU intravenous\]
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ghady Haidar
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator
Citations
Bacteriophages for Adults With Cystic Fibrosis and Chronic ...
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 ...
2.
ctv.veeva.com
ctv.veeva.com/study/bacteriophages-for-adults-with-cystic-fibrosis-and-chronic-achromobacter-lung-infectionBacteriophages for Adults With Cystic Fibrosis and Chronic ...
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 ...
The Efficacy of an N-Acetylcysteine–Antibiotic Combination ...
The Efficacy of an N-Acetylcysteine–Antibiotic Combination Therapy on Achromobacter xylosoxidans in a Cystic Fibrosis Sputum/Lung Cell Model - PMC.
Role of Bacteriophage in Cystic Fibrosis Treatment
Results from the Phase IIa cystic fibrosis trial involving 41 cystic fibrosis patients indicated favorable outcomes with inhaled AR-501. The ...
5.
respiratory-therapy.com
respiratory-therapy.com/disorders-diseases/chronic-pulmonary-disorders/cystic-fibrosis/trial-data-vertex-cf-therapies-benefits/Latest Trial Data on Vertex CF Therapies and New Combos ...
An interim analysis at 48 weeks of treatment showed that Orkambi improved the patients' lung function, sweat chloride and body mass index. Read more at ...
Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis
Inhaled antibiotics may be used alone or in conjunction with oral antibiotics for milder exacerbations or with intravenous antibiotics for more severe ...
Cystic Fibrosis: Recent Insights into Inhaled Antibiotic ...
Controlled clinical and real-world studies have shown that TIP, delivered via the T-326 Inhaler, had a safety and efficacy profile comparable to TIS, with ...
Inhaled antibiotics for pulmonary exacerbations in cystic ...
Inhaled antibiotics may be used alone or in conjunction with oral antibiotics for milder exacerbations or with intravenous antibiotics for more severe ...
9.
researchgate.net
researchgate.net/publication/330487369_Developing_Inhaled_Antibiotics_in_Cystic_Fibrosis_Current_Challenges_and_Opportunities(PDF) Developing Inhaled Antibiotics in Cystic Fibrosis
... data, in particular with respect to safety endpoints but also with. other efficacy measures such as pulmonary exacerbation risk. An emphasis ...
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