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Virus Therapy

Bacteriophage Therapy for Cystic Fibrosis

Phase 1 & 2
Waitlist Available
Research Sponsored by BiomX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing if a new drug is safe and if it can help reduce infection in people with CF.

Who is the study for?
Adults over 18 with cystic fibrosis and chronic lung infection caused by Pseudomonas aeruginosa can join. They must be clinically stable, able to produce sputum samples, and have a certain level of lung function (FEV1 ≥ 40%). Excluded are those with severe immune issues, prior bacteriophage therapy within six months, specific ongoing treatments for other conditions, or recent changes in CF modulator therapy.Check my eligibility
What is being tested?
The trial is testing BX004-A, a nebulized bacteriophage therapy against a placebo. The main goal is to check if it's safe and tolerable for patients. Researchers will also explore whether this treatment reduces the amount of Pseudomonas bacteria in the lungs.See study design
What are the potential side effects?
While not specified here, common side effects from similar therapies may include respiratory symptoms like coughing or wheezing due to inhalation of the substance; allergic reactions; fatigue; and gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have cystic fibrosis with a chronic lung infection due to Pseudomonas aeruginosa and am on standard CF treatments.
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I am 18 years old or older.
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My lung condition is currently stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability
Other outcome measures
PsA burden in sputum at various timepoints

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BX004-AExperimental Treatment1 Intervention
Participants will be randomized to receive standard dose of nebulized bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive nebulized placebo

Find a Location

Who is running the clinical trial?

BiomX, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Xilla Ussery, MDStudy DirectorBiomX, Inc.
Urania Rappo, MDStudy DirectorBiomX, Inc.
5 Previous Clinical Trials
749 Total Patients Enrolled

Media Library

BX004-A (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05010577 — Phase 1 & 2
Cystic Fibrosis Research Study Groups: Placebo, BX004-A
Cystic Fibrosis Clinical Trial 2023: BX004-A Highlights & Side Effects. Trial Name: NCT05010577 — Phase 1 & 2
BX004-A (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010577 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accessible to patients in urban areas?

"Central Florida Pulmonary Group in Orlando, Florida, Boston Children's Hospital in Boston, Massachusetts, and Joe DiMaggio Children's Hospital in Hollywood, New york are all active participants in this clinical trial. Additionally, there are 7 other sites across the nation taking part."

Answered by AI

How many total individuals are taking part in this research?

"The correct, this particular study is recruiting patients according to the information available on clinicaltrials.gov. This specific trial was originally posted on 6/21/2022 and updated on 6/28/2022. They are looking for 32 individuals across 7 sites."

Answered by AI

Are there any available vacancies for test subjects in this experiment?

"That is correct. The information available on clinicaltrials.gov affirms that this particular trial is open and recruiting patients as of right now. This study was first made public on 6/21/2022 and the most recent update was on 6/28/2022. In total, 32 individuals are needed to complete this research project at 7 different locations."

Answered by AI
~12 spots leftby Feb 2025