NCT07275905

Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

A Phase 1, Open-label, Randomized, Pilot and Feasibility Trial to Evaluate the Safety and Tolerability of the Achromobacter-targeting Bacteriophage Cocktail, AchromoPhage, Among Persons With Cystic Fibrosis and Chronic Achromobacter Lung Infections: The AchromoPhage Trial

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Ghady Haidar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

AchromoPhage is a naturally derived bacteriophage cocktail composed of four genetically distinct, obligately lytic phages (phiACH01, phiACH04, phiACH06, and phiACH07) with demonstrated in vitro activity against Achromobacter species. The cocktail showed activity against more than 75% of a panel of 17 genetically diverse Achromobacter isolates collected from adults with cystic fibrosis. This study is designed to evaluate the safety and tolerability of AchromoPhage in adults with cystic fibrosis who have chronic Achromobacter lung infection. This is an open-label, randomized Phase 1 pilot and feasibility trial conducted at two sites: the University of Pittsburgh, which will serve as the coordinating center, and the University of California San Diego. Eligible participants will be randomized to receive AchromoPhage by one of three delivery routes: inhaled administration, intravenous administration, or sequential inhaled followed by intravenous administration in the same visit. Each participant will receive three weekly administrations with escalating doses. In addition to evaluating safety and tolerability, the trial will assess lung function and health-related quality of life, characterize pharmacokinetic profiles of AchromoPhage in blood and airway samples, and evaluate the humoral immune response to the administered phages. Exploratory analyses will examine pharmacodynamic effects, including changes in Achromobacter abundance, bacterial community profiles, antibiotic-phage interactions, and phage-pathogen dynamics.

Conditions

• Cystic Fibrosis (CF)
• Achromobacter Infection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-01-01
• Completion: 2028-02-01
• First posted: 2025-12-10
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study