Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

Conditions

• Achromobacter Infection
• Cystic Fibrosis (CF)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AchromoPhage — BIOLOGICAL
  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).

Study Details

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).

Key Dates

Start date

May 1, 2026

Status verified

Feb 2026

Primary completion

Jan 31, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inhaled Alone Arm
  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
• Experimental: Intravenous Alone Arm
  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
• Experimental: Combination Inhaled + Intravenous Arm
  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 \[i.e. 4×10⁹ total PFU inhaled, followed by a 60-minute wait, then 4×10⁹ total PFU intravenous\]

Primary Outcome Measure

Incidence of treatment-related Grade ≥4 adverse events or treatment-limiting toxicities [ Time Frame: 42 Days ]

Central Contacts

• Breuna N Bishop - Program Manager, Pittsburgh Phage Program, MSE
  412-368-6380
  [email protected]
• Kailey Hughes Kramer - Director, Translational Research Unit, PhD MPH
  412-648-6453
  [email protected]

Locations (2)

Find similar trials in San Diego, CA

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