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Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

NCT07275905 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-07

No results posted yet for this study

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).

Conditions

  • Cystic Fibrosis (CF)
  • Achromobacter Infection

Interventions

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).

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Ghady Haidar

    lead OTHER

Principal Investigators

  • Ghady Haidar, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-01-31
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07275905 on ClinicalTrials.gov