CF - Cystic FibrosisPhase 1NCT07280598
Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections
A Phase 1 study testing Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics in people with CF - Cystic Fibrosis and Klebsiella Pneumoniae Infection, run by University of California, San Diego.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CF - Cystic Fibrosis, Klebsiella Pneumoniae Infection, E Coli Infections
- What is being tested?
- Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 30 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participation in another interventional trial within 30 days.
- Allergy or hypersensitivity to study materials.
- Pregnancy, planned pregnancy, or breastfeeding.
- Any condition or abnormality that, in the investigator's judgment, makes participation unsafe or may interfere with study assessments.
About this study
Official title: Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)
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.
Read the detailed description
Cystic fibrosis (CF) is a genetic disease characterized by chronic and recurrent pulmonary infections, often caused by antibiotic-resistant bacteria. These infections contribute significantly to lung function decline, reduced quality of life, and early mortality. Given the rising prevalence of antimicrobial resistance (AMR) and limited efficacy of conventional antibiotic therapies, there is an urgent need for novel therapeutic strategies. Bacteriophage (phage) therapy-using viruses that infect and lyse specific bacteria-has emerged as a promising, targeted approach for managing drug-resistant bacterial infections.
This is a Phase 1, open-label, multi-center pilot study designed to assess the safety, tolerability, and preliminary biological activity of intravenous (IV) bacteriophage therapy administered in combination with standard IV antibiotics in adults with CF experiencing a pulmonary exacerbation caused by antibiotic-resistant bacterial pathogens. Participants must have a confirmed diagnosis of CF and recent culture-proven infection with one of six target bacteria: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.
The study will enroll up to 30 participants across three U.S. clinical sites. Eligible subjects will receive a 7-day course of IV antibiotics prescribed by their clinical team, along with a pathogen-specific four-phage cocktail administered twice daily through a peripherally inserted central catheter (PICC). The phage cocktails are prepared under GMP conditions and have demonstrated lytic activity against clinical isolates of each target pathogen.
The primary endpoint is to evaluate the safety and tolerability of the combined phage-antibiotic therapy by monitoring adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs). Secondary endpoints include changes in bacterial load in sputum (colony counts and qPCR), changes in lung function (spirometry and oscillometry), and patient-reported quality of life measures. An exploratory endpoint includes characterizing the pharmacokinetic profile of IV phage therapy in serum and sputum.
Initial doses of phage will be administered under direct clinical observation to monitor for immediate reactions. If well-tolerated, subsequent doses may be self-administered at home. Follow-up assessments will be conducted up to 28 days post-treatment, with additional safety monitoring extending up to 217 days. The trial is not designed to support regulatory approval but to generate essential safety and feasibility data to guide future efficacy trials in this high-need patient population.
- Conditions
- CF - Cystic Fibrosis, Klebsiella Pneumoniae Infection, E Coli Infections, Staphylococcus Aureus Infection, Achromobacter, Stenotrophomonas Maltophilia Infection
- Being tested
- Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics
- Keywords
- cystic fibrosis, CF, Phage, bacteriophage
- Medical subject headings
- Cystic Fibrosis, Escherichia coli Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Bacteriophage Cocktail plus Standard IV AntibioticsDrug
Participants will receive a seven-day course of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics. The bacteriophage therapy consists of a pathogen-specific cocktail containing four purified, lytic bacteriophages selected based on pre-treatment sensitivity testing of the participant's bacterial isolate. Each phage cocktail targets one of the following antibiotic-resistant pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. Phage cocktails are administered IV twice daily at a concentration of 1x10⁹ PFU/mL, following antibiotic infusion. The first three doses are observed in clinic; remaining doses are self-administered at home via PICC line. All phages are produced under GMP conditions and screened to be lytic-only, free of known toxin, resistance, or lysogeny genes.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Study of Combined IV Antibiotics and Bacteriophage Therapy for Antibiotic-Res | Experimental | This arm will evaluate the safety and microbiological activity of a combined intravenous (IV) antibiotic and bacteriophage therapy in adults with cystic fibrosis (CF) who are experiencing pulmonary exacerbations caused by antibiotic-resistant bacterial pathogens. Participants will receive a clinician-selected, standard IV antibiotic regimen for 7 days, administered twice daily. In parallel, participants will receive a matched, pathogen-specific bacteriophage cocktail via IV infusion, also administered twice daily for 7 days. The phage cocktails consist of four lytic bacteriophages targeting one of the following pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. The first three phage doses will be administered in a monitored clinic setting; remaining doses will be self-administered at home via PICC line. This is a Phase 1, open-label, multi-site pilot study focused on safety. Receives: Drug: Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of combined IV antibiotic and bacteriophage therapy assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs)
Safety will be assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs) during and following the 7-day treatment period, in accordance with CTCAE criteria. Monitoring will occur from the initiation of the study drug through the 28-day follow-up period.
Measured: Baseline (Day -14 to Day 1) through Day 28 ± 5
Secondary outcomes (4)
Microbiological activity of combined IV antibiotic and bacteriophage therapy
Assessed by changes in bacterial burden in expectorated sputum samples, measured by quantitative culture (CFU/mL) and qPCR for the target pathogen. A response is defined as a ≥0.5 log reduction in bacterial load from baseline.
Measured: Baseline (Day -14 to Day 1) through Day 28 ± 5
Microbiological Response: Sputum Bacterial Load (Quantitative Culture) measured by quantitative culture
Change in Sputum Bacterial Load (Quantitative Culture) measured by quantitative culture.
Time Frame: Baseline to Day 36 Unit of Measure: CFU/mL
Measured: From the first dose through 28 days after the last dose of study treatment
Change in Lung Function (FEV₁ Percent Predicted) measured by percent predicted forced expiratory volume in one second (FEV₁ % predicted).
Change in Lung Function (FEV₁ Percent Predicted) measured by percent predicted forced expiratory volume in one second (FEV₁ % predicted).
Unit of Measure: Percent predicted
Measured: Baseline to Day 36
Change in Respiratory Symptoms Using the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (Cystic Fibrosis Respiratory Symptom Diary-CRISS)
Change in Respiratory Symptoms Using the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (Cystic Fibrosis Respiratory Symptom Diary-CRISS). Scores range from 0 (no symptoms) to 100 (most severe symptoms). Unit of Measure: Units on a 0-100 scale
Measured: Baseline to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CF - Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pride, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280598
- Sponsor's protocol ID
- 812895
- Other IDs
- 314645-00001
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)
- ClinicalTrials.gov ID
- NCT07280598
- Acronym / sponsor ID
- 812895
- Conditions
- CF - Cystic Fibrosis, Klebsiella Pneumoniae Infection, E Coli Infections, Staphylococcus Aureus Infection, Achromobacter, Stenotrophomonas Maltophilia Infection
- Keywords
- cystic fibrosis, CF, Phage, bacteriophage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cystic fibrosis (CF) is a genetic disease characterized by chronic and recurrent pulmonary infections, often caused by antibiotic-resistant bacteria. These infections contribute significantly to lung function decline, reduced quality of life, and early mortality. Given the rising prevalence of antimicrobial resistance (AMR) and limited efficacy of conventional antibiotic therapies, there is an urgent need for novel therapeutic strategies. Bacteriophage (phage) therapy-using viruses that infect and lyse specific bacteria-has emerged as a promising, targeted approach for managing drug-resistant bacterial infections.
This is a Phase 1, open-label, multi-center pilot study designed to assess the safety, tolerability, and preliminary biological activity of intravenous (IV) bacteriophage therapy administered in combination with standard IV antibiotics in adults with CF experiencing a pulmonary exacerbation caused by antibiotic-resistant bacterial pathogens. Participants must have a confirmed diagnosis of CF and recent culture-proven infection with one of six target bacteria: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.
The study will enroll up to 30 participants across three U.S. clinical sites. Eligible subjects will receive a 7-day course of IV antibiotics prescribed by their clinical team, along with a pathogen-specific four-phage cocktail administered twice daily through a peripherally inserted central catheter (PICC). The phage cocktails are prepared under GMP conditions and have demonstrated lytic activity against clinical isolates of each target pathogen.
The primary endpoint is to evaluate the safety and tolerability of the combined phage-antibiotic therapy by monitoring adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs). Secondary endpoints include changes in bacterial load in sputum (colony counts and qPCR), changes in lung function (spirometry and oscillometry), and patient-reported quality of life measures. An exploratory endpoint includes characterizing the pharmacokinetic profile of IV phage therapy in serum and sputum.
Initial doses of phage will be administered under direct clinical observation to monitor for immediate reactions. If well-tolerated, subsequent doses may be self-administered at home. Follow-up assessments will be conducted up to 28 days post-treatment, with additional safety monitoring extending up to 217 days. The trial is not designed to support regulatory approval but to generate essential safety and feasibility data to guide future efficacy trials in this high-need patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Study of Combined IV Antibiotics and Bacteriophage Therapy for Antibiotic-Res | Experimental | Drug: Intravenous Bacteriophage Cocktail plus Standard IV AntibioticsThis arm will evaluate the safety and microbiological activity of a combined intravenous (IV) antibiotic and bacteriophage therapy in adults with cystic fibrosis (CF) who are experiencing pulmonary exacerbations caused by antibiotic-resistant bacterial pathogens. Participants will receive a clinician-selected, standard IV antibiotic regimen for 7 days, administered twice daily. In parallel, participants will receive a matched, pathogen-specific bacteriophage cocktail via IV infusion, also administered twice daily for 7 days. The phage cocktails consist of four lytic bacteriophages targeting one of the following pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. The first three phage doses will be administered in a monitored clinic setting; remaining doses will be self-administered at home via PICC line. This is a Phase 1, open-label, multi-site pilot study focused on safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Participation in another interventional trial within 30 days.
- Allergy or hypersensitivity to study materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Bacteriophage Cocktail plus Standard IV AntibioticsParticipants will receive a seven-day course of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics. The bacteriophage therapy consists of a pathogen-specific cocktail containing four purified, lytic bacteriophages selected based on pre-treatment sensitivity testing of the participant's bacterial isolate. Each phage cocktail targets one of the following antibiotic-resistant pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. Phage cocktails are administered IV twice daily at a concentration of 1x10⁹ PFU/mL, following antibiotic infusion. The first three doses are observed in clinic; remaining doses are self-administered at home via PICC line. All phages are produced under GMP conditions and screened to be lytic-only, free of known toxin, resistance, or lysogeny genes. | Drug | Phase 1 Study of Combined IV Antibiotics and Bacteriophage Therapy for Antibiotic-Res |
Primary outcome
Safety and tolerability of combined IV antibiotic and bacteriophage therapy assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs)
Time frame: Baseline (Day -14 to Day 1) through Day 28 ± 5
Safety will be assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs) during and following the 7-day treatment period, in accordance with CTCAE criteria. Monitoring will occur from the initiation of the study drug through the 28-day follow-up period.
4 secondary outcomes
Microbiological activity of combined IV antibiotic and bacteriophage therapy
Time frame: Baseline (Day -14 to Day 1) through Day 28 ± 5
Microbiological Response: Sputum Bacterial Load (Quantitative Culture) measured by quantitative culture
Time frame: From the first dose through 28 days after the last dose of study treatment
Change in Lung Function (FEV₁ Percent Predicted) measured by percent predicted forced expiratory volume in one second (FEV₁ % predicted).
Time frame: Baseline to Day 36
Change in Respiratory Symptoms Using the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (Cystic Fibrosis Respiratory Symptom Diary-CRISS)
Time frame: Baseline to Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics in people with CF - Cystic Fibrosis and Klebsiella Pneumoniae Infection, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of combined IV antibiotic and bacteriophage therapy assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs) (time frame: Baseline (Day -14 to Day 1) through Day 28 ± 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.