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Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07429162
Enrollment
1
Registered
2026-02-24
Start date
2026-07-02
Completion date
2028-07-02
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteriophage Therapy, Mycobacterium Abscessus Infection, Pulmonary Disease

Brief 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 improving pulmonary outcomes.

Interventions

BIOLOGICALDP-QB-MYA-002

In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss

Sponsors

Alberta Health services
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consent to participation

Exclusion criteria

* non-consent to participation

Design outcomes

Primary

MeasureTime frameDescription
Time to Sputum Culture Conversion (Microbiologic Response)1 yearSerial AFB smear grading and serial mycobacterial sputum cultures during and post treatment

Secondary

MeasureTime frameDescription
Change in Volume of Sputum Production (Clinical Response)1 yearPatient Report
Change in frequency of Cough (Clinical Response)1 yearPatient Report
Change in FEV1 (Clinical Response)1 yearThis 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.
Change in BMI (Clinical Response)1 yearWithin 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.
Radiographic Response1 yearChest 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026