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Clinical Trial Finder
Anti-Infective Enrolling
Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a) (BiomX BMX-04-001 Part 1)
This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.
This study will take place in two parts that are both randomized and placebo-controlled. This means that some participants will be randomly assigned to receive the study drug, and some participants will be randomly assigned to receive placebo. In Part 1, participants will be given single doses at different dose levels and multiple doses of BX004-A or placebo. In Part 2, participants will be given multiple doses of BX004-A or placebo. Participants in both parts will be included in a 6-month safety follow-up. Researchers will measure the safety and tolerability of the drug. They will also measure PsA levels in sputum to see if the drug reduces bacterial load.
This study may require sputum or throat swab collection, and/or additional procedures.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants must have a chronic pulmonary Pseudomonas aeruginosa infection: defined as PsA isolated within the 6-12 months prior to Screening and currently receiving inhaled aztreonam or tobramycin.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
189 days -
Number of Study Visits:
7
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
BiomX -
Study Drugs:
Study Sites
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Enrolling
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hyhathorne@uabmc.edu
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Enrolling Soon
Alaska
Providence Alaska Medical Center, Anchorage, AK 99508
Contact
Emlynne Villanos
Phone: +1 (907) 212-3299
Email: emlynnemae.villanos@providence.org
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Enrolling Soon
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
Contact
Kathleen Hicks
Phone: +1 (501) 686-5527
Email: HicksKathleenT@uams.edu
-
Enrolling Soon
Connecticut
Yale University School of Medicine, New Haven, CT 06520
Contact
Jonathan Koff
Phone: +1 (203) 737-6963
Email: jon.koff@yale.edu
-
Enrolling Soon
District of Columbia
Children's National Medical Center, Washington, DC 20010
Contact
Jack Serio
Phone: +1 (202) 476-2420
Email: jserio@childrensnational.org
-
Enrolling
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
-
Enrolling Soon
Florida
University of Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
-
Enrolling
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
Contact
Doris Alaby
Phone: +1 (954) 265-1863
Email: dalaby@mhs.net
-
Enrolling
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
-
Enrolling
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Tracy Mosely
Phone: +1 (832) 822-3309
Email: tlmosely@texaschildrens.org
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Enrolling Soon
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
Contact
Kristyn Packer
Phone: +1 (801) 585-0401
Email: kristyn.packer@hsc.utah.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater -
Pseudomonas Status:
Positive Respiratory Cultures Required
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants must have a chronic pulmonary Pseudomonas aeruginosa infection: defined as PsA isolated within the 6-12 months prior to Screening and currently receiving inhaled aztreonam or tobramycin.
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