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A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

Testing bacteriophage therapy for cystic fibrosis with Pseudomonas aeruginosa.

Recruiting
18 years and older
All
Phase 1/2

This study is for adults with Cystic Fibrosis (CF) who have a specific lung infection called Pseudomonas aeruginosa. The study will test if a special treatment, called bacteriophage therapy, is safe and helps fight the infection. Bacteriophages are tiny viruses that can kill bacteria. This treatment is given through an IV, which means it goes directly into your bloodstream. The study will take place at up to 20 locations in the USA.

In the first stage, 6 people will try different doses of this treatment. If it seems safe, more people will join to find the best dose. The study will last about 30 days and you will need to attend several visits.

  • The study involves several visits within a month.
  • Participants will receive the study treatment or a placebo (a harmless substance).
  • The study checks for any side effects and the treatment's effectiveness.

To join, you must be at least 18, have CF, and have had the infection before. Pregnant women or those with certain medical issues can't join. If interested, discuss with your doctor.

Study details
    Bacterial Disease Carrier
    Cystic Fibrosis

NCT05453578

National Institute of Allergy and Infectious Diseases (NIAID)

16 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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