Mycobacterium Abscessus InfectionPhase 1NCT07429162
Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
A Phase 1 study testing DP-QB-MYA-002 in people with Mycobacterium Abscessus Infection and Bacteriophage Therapy, run by Alberta Health services.
Trial summary
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Abscessus Infection, Bacteriophage Therapy, Pulmonary Disease
- What is being tested?
- DP-QB-MYA-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2026to 2 Jul 2028
- 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
- Consent to participation
Who cannot join
- non-consent to participation
About this study
Official title: DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.
- Being tested
- DP-QB-MYA-002
- Medical subject headings
- Mycobacterium Infections, Nontuberculous, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-QB-MYA-002Biological
In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Use of Mycobacteriophage Receives: Biological: DP-QB-MYA-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sputum Culture Conversion (Microbiologic Response)
Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment
Measured: 1 year
Secondary outcomes (5)
Change in Volume of Sputum Production (Clinical Response)
Patient Report
Measured: 1 year
Change in frequency of Cough (Clinical Response)
Patient Report
Measured: 1 year
Change in FEV1 (Clinical Response)
This will be assessed via spirometry at baseline and at the end of the study An increase in FEV1 indicating improvement in lung function or FEV1 decrease indicating decline in lung function.
Measured: 1 year
Change in BMI (Clinical Response)
Within subject change in BMI measured in kg/m^2. Increase in BMI as a sign of improvement. Decline in BMI as sign of decline or worse outcome.
Measured: 1 year
Radiographic Response
Chest imaging response (CT scan) to treatment. Reduction in size, number or density of pulmonary nodules indicating improvement, whereas increased size, number or density indicating worsening.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start2 Jul 2026 (estimated)
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus InfectionStudies of the same condition, open and under way.
- 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Edwards, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429162
- Sponsor's protocol ID
- PHAGE-2026-01
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
- ClinicalTrials.gov ID
- NCT07429162
- Acronym / sponsor ID
- PHAGE-2026-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- 2 Jul 2026 (estimated)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Jul 2028 (estimated)
- First posted
- 24 Feb 2026 (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.
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: DP-QB-MYA-002Use of Mycobacteriophage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consent to participation
Key exclusion criteria (1 listed)
- non-consent to participation
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 |
|---|---|---|
| DP-QB-MYA-002In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss | Biological | Treatment |
Primary outcome
Time to Sputum Culture Conversion (Microbiologic Response)
Time frame: 1 year
Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment
5 secondary outcomes
Change in Volume of Sputum Production (Clinical Response)
Time frame: 1 year
Change in frequency of Cough (Clinical Response)
Time frame: 1 year
Change in FEV1 (Clinical Response)
Time frame: 1 year
Change in BMI (Clinical Response)
Time frame: 1 year
Radiographic Response
Time frame: 1 year
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 24 Feb 2026.
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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 DP-QB-MYA-002 in people with Mycobacterium Abscessus Infection and Bacteriophage Therapy, run by Alberta Health services.
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 1 inclusion and 1 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 24 Feb 2026. 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?
Time to Sputum Culture Conversion (Microbiologic Response) (time frame: 1 year). 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 24 Feb 2026.