- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616221
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (Tailwind)
December 21, 2023 updated by: Armata Pharmaceuticals, Inc.
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior.
Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior.
Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pierre Kyme, PhD
- Phone Number: 234 310-665-2928
- Email: pkyme@armatapharma.com
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36608
- Recruiting
- Velocity Clinical Research
-
Principal Investigator:
- Lawrence Sindel, MD
-
Contact:
- Danny Kakish
- Phone Number: 251-263-5669
- Email: dkakish@velocityclinical.com
-
-
California
-
Los Angeles, California, United States, 90048
- Recruiting
- Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
-
Contact:
- Francesca Caputo
- Phone Number: 127 310-657-1230
- Email: fcaputo@towertrials.com
-
Principal Investigator:
- Andrew Watchtel, MD
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- Recruiting
- UCONN Health
-
Principal Investigator:
- Mark Metersky, MD
-
Contact:
- Malik Qasim
- Phone Number: 860-679-4219
- Email: qmalik@uchc.edu
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Recruiting
- Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
-
Principal Investigator:
- Anne O'Donnell, MD
-
Contact:
- Amen Hamed
- Phone Number: 202-444-8830
- Email: Amen.M.Hamed@gunet.georgetown.edu
-
-
Florida
-
Fort Myers, Florida, United States, 33907
- Recruiting
- Southwest General Healthcare Center
-
Principal Investigator:
- Jose Rodriguez, MD
-
Contact:
- Daniela Pargas
- Phone Number: 239-931-3368
- Email: daniela.swghcc@gmail.com
-
Hollywood, Florida, United States, 33024
- Recruiting
- TecTum Medical Research, Inc.
-
Contact:
- Carla Navas
- Phone Number: 954-322-8985
- Email: carla.navas@tectumresearch.com
-
Principal Investigator:
- Juan C Rondon, MD
-
Jacksonville, Florida, United States, 32224
- Active, not recruiting
- Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
-
Miami, Florida, United States, 33146
- Recruiting
- University of Miami
-
Contact:
- Ivan Whitaker
- Phone Number: 305-243-2568
- Email: yiw2@miami.edu
-
Principal Investigator:
- Maria Tupayachi, MD
-
-
Idaho
-
Boise, Idaho, United States, 83702
- Recruiting
- St. Lukes Hospital
-
Contact:
- Lejla Godusevic
- Phone Number: 208-381-4717
- Email: godusevl@slhs.org
-
Principal Investigator:
- Karen Miller, MD
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- The University of Kansas Medical Center / Dept of Medicine
-
Contact:
- Megan Behrman
- Phone Number: 913-588-6031
- Email: mbehrman@kumc.edu
-
Principal Investigator:
- Andreas Schmid, MD
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins University School of Medicine
-
Contact:
- Jan Nguyen
- Phone Number: 667-306-7509
- Email: j.nguyen@jhmi.edu
-
Principal Investigator:
- Daniel Belz, MD
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Active, not recruiting
- Mayo Clinic
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Robert Wood Johnson Medical School
-
Principal Investigator:
- Sugeet Jagpal, MD
-
Contact:
- Halina Malveaux
- Phone Number: 732-235-6402
- Email: malveaha@rwjms.rutgers.edu
-
-
New York
-
Hawthorne, New York, United States, 10595
- Recruiting
- New York Medical College
-
Contact:
- Armando Ramirez
- Phone Number: 914-594-2352
- Email: armando_ramirez@bchphysicians.org
-
Principal Investigator:
- John Welter, MD
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals of Cleveland Medical Center
-
Principal Investigator:
- Alex Gifford, MD
-
Contact:
- Jennie Pexa
- Phone Number: 216-844-2381
- Email: Jennie.Pexa@UHhospitals.org
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Sarah Siegel
- Phone Number: 503-494-1384
- Email: siegels@ohsu.edu
-
Principal Investigator:
- Kevin Winthrop, MD
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennslyvania
-
Principal Investigator:
- Daniel Dorgan, MD
-
Contact:
- Melissa Molter
- Phone Number: 215-662-3116
- Email: melissa.molter@pennmedicine.upenn.edu
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Principal Investigator:
- Patrick Flume, MD
-
Contact:
- Angela Millare
- Phone Number: 843-792-3167
- Email: millare@musc.edu
-
-
Texas
-
Tyler, Texas, United States, 75708
- Recruiting
- University of Texas Health Science Center at Tyler
-
Principal Investigator:
- Pamela McShane, MD
-
Contact:
- Kimberly Greenlee
- Phone Number: 903-877-5986
- Email: Kimberly.Greenlee@uthct.edu
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washington Medical Center
-
Principal Investigator:
- Christopher Goss, MD
-
Contact:
- Roshni Prabhu
- Phone Number: 206-616-1058
- Email: rprabhu@uw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AP-PA02
Anti-pseudomonal bacteriophage
|
Bacteriophage administered via inhalation
|
Placebo Comparator: Placebo
Inactive isotonic solution
|
Inactive Placebo administered via inhalation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
Time Frame: Day 1 pre-dose through 7 days post last dose of study drug
|
Day 1 pre-dose through 7 days post last dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mina Pastagia, MD, Armata Pharmaceuticals, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 15, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP-PA02-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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