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

February 17, 2026 updated by: Jenny Edwards, Alberta Health services

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consent to participation

Exclusion Criteria:

  • non-consent to participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Use of Mycobacteriophage
Biological: DP-QB-MYA-002
In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Sputum Culture Conversion (Microbiologic Response)
Time Frame: 1 year
Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Volume of Sputum Production (Clinical Response)
Time Frame: 1 year
Patient Report
1 year
Change in frequency of Cough (Clinical Response)
Time Frame: 1 year
Patient Report
1 year
Change in FEV1 (Clinical Response)
Time Frame: 1 year
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.
1 year
Change in BMI (Clinical Response)
Time Frame: 1 year
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.
1 year
Radiographic Response
Time Frame: 1 year
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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects (Clinical)
Time Frame: 1 year
Adverse clinical and laboratory events (number and severity) on treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 2, 2026

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

July 2, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAGE-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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