NCT07280598Not yet recruitingPhase 1
Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections
Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
This is a Phase 1, open-label, multi-center pilot study evaluating the safety and microbiological activity of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics in adults with cystic fibrosis (CF) experiencing pulmonary exacerbations due to antibiotic-resistant bacterial infections. Eligible participants will receive a 7-day course of IV antibiotics, selected by their treating clinician, along with a phage cocktail specifically formulated to target their identified bacterial pathogen (Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans). The primary objective is to assess the safety and tolerability of this combined treatment approach. Secondary and exploratory outcomes include assessment of changes in sputum bacterial burden, lung function (spirometry and oscillometry), quality of life, and bacteriophage pharmacokinetics. Results from this study will inform the feasibility and design of future clinical trials using phage therapy in the CF population.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 31 Dec 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of California, San Diego
- Diseases
- Cystic fibrosis
- NCT number
- NCT07280598
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 31 Dec 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Untreated or uncontrolled mycobacterial or fungal airway infection.
- History of Clostridioides difficile without a negative test within 3 months. Concerning exotoxin, virulence, or resistance genes in the bacterial isolate (per investigator).
- Mixed-species bacterial infection at screening.
- Allergy or hypersensitivity to study materials.
- Any condition or abnormality that, in the investigator's judgment, makes participation unsafe or may interfere with study assessments.
Other
- Participation in another interventional trial within 30 days.
- Pregnancy, planned pregnancy, or breastfeeding.
Who the study is looking for
- Age ≥ 18 years.
- Confirmed diagnosis of cystic fibrosis.
- Sputum culture within 24 months and at screening showing at least one of the following: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.
- Percent predicted FEV₁ ≥ 40% (GLI).
- If ppFEV₁ \> 40%, must have ≥ 1 pulmonary exacerbation per year requiring IV antibiotics or radiographic evidence of severe disease.
- Prior successful home IV antibiotic therapy within 5 years (may be waived by investigator).
- Available phage cocktail with lytic activity against the participant's pathogen.
- Oxygen saturation \> 88% on room air after rest. Able to provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.