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Virus cocktail inhaled to fight Drug-Resistant lung infection

NCT ID NCT05616221

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

  • Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine

    Washington D.C., District of Columbia, 20007, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • New York Medical College

    Hawthorne, New York, 10595, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower

    Los Angeles, California, 90048, United States

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907, United States

  • St. Lukes Hospital

    Boise, Idaho, 83702, United States

  • TecTum Medical Research, Inc.

    Hollywood, Florida, 33024, United States

  • The University of Kansas Medical Center / Dept of Medicine

    Kansas City, Kansas, 66160, United States

  • UCONN Health

    Farmington, Connecticut, 06030, United States

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Cincinnati - College of Medicine

    Cincinnati, Ohio, 45267, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Pennslyvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

  • Velocity Clinical Research

    Mobile, Alabama, 36608, United States

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia, 23298, United States

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