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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 safety for cystic fibrosis with Pseudomonas infections.

Not Recruiting
18 years and older
All
Phase 1/2

This study tests bacteriophage therapy for people with Cystic Fibrosis (CF), a lung disease. A bacteriophage is a virus that attacks bacteria. The study focuses on people who have a lung infection caused by the bacteria Pseudomonas aeruginosa. Participants will get one dose of bacteriophage therapy through an IV, which means medicine is given through a needle into a vein. The study checks safety and how well the treatment works. It will take place in the US at up to 20 sites.

In Stage 1, the therapy will be tested on six people. If no serious side effects appear, the study will move to Stage 2, including more people. Participants will be randomly placed in groups receiving either the bacteriophage or a placebo (a harmless substance used to compare results).

  • Participants must be 18 or older with CF and a confirmed infection from the bacteria.
  • The study lasts about a month with several visits.
  • Participants must not change chronic medications during the study and must not be pregnant or planning to be.
Study details
    Bacterial Disease Carrier
    Cystic Fibrosis

NCT05453578

National Institute of Allergy and Infectious Diseases (NIAID)

3 September 2026

FAQs

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.

How safe are clinical trials?

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