Virus cocktail inhaled to fight Drug-Resistant lung infection
NCT ID NCT05616221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an inhaled mixture of bacteria-killing viruses (phages) in 48 adults with bronchiectasis and chronic Pseudomonas lung infections. Participants received either the phage therapy or a placebo by inhalation. The goal was to see if the phages could safely reduce the amount of bacteria in the lungs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AP-PA02 (a mixture of viruses that kill bacteria, called bacteriophages, inhaled as a mist)
- What this could lead to
- If it works, this could offer a new way to control stubborn lung infections in people with bronchiectasis, reducing the need for antibiotics.
- What could go wrong
- This is a small, early-phase trial with only 48 participants. The treatment may not reduce bacteria enough, and side effects from inhaling phages are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * ≥ 18 years old * Body mass index (BMI) of ≥ 18 kg/m2 * Evidence of bronchiectasis per CT * Evidence of chronic pulmonary Pseudomonas aeruginosa infection * Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate) * FEV1 ≥ 35% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening * For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1 * For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1 Key Exclusion Criteria: * Abnormal vital signs at Screening * History of lung transplantation * History of cystic fibrosis * History of α1-antitrypsin deficiency * History of primary or acquired immunodeficiency syndromes * History of COPD * History of pulmonary malignancy or any other malignancy requiring treatment * History of prolonged QT syndrome * History of hemoptysis * Recent significant weight loss * Recent use of supplemental oxygen during the day while at rest * Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping * Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids * Currently receiving treatment for active infection at any site * Female pregnant of breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington D.C., District of Columbia, 20007, United States
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Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida, 32224, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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New York Medical College
Hawthorne, New York, 10595, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
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Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California, 90048, United States
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Southwest General Healthcare Center
Fort Myers, Florida, 33907, United States
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St. Lukes Hospital
Boise, Idaho, 83702, United States
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TecTum Medical Research, Inc.
Hollywood, Florida, 33024, United States
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The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas, 66160, United States
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UCONN Health
Farmington, Connecticut, 06030, United States
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University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of Cincinnati - College of Medicine
Cincinnati, Ohio, 45267, United States
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University of Miami
Miami, Florida, 33146, United States
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University of Pennslyvania
Philadelphia, Pennsylvania, 19104, United States
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University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
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Velocity Clinical Research
Mobile, Alabama, 36608, United States
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Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a Pulsed-Air device revolutionize mucus clearance for bronchiectasis?
- A vibrating vest may help children with damaged lungs breathe easier
- Can a new biologic drug delay dangerous lung Flare-Ups?
- Inhaled experimental drug targets tough lung infections
- New drug trial aims to tame chronic lung infections
- Scientists develop risk score to forecast bronchiectasis attacks