Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

May 30, 2026 updated by: William Connors, Vancouver Coastal Health

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection: An Open Label Individual Patient Study

This study aims to use mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with Mycobacterium abscessus with goal to reduce infection burden and improve pulmonary disease

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Hypothesis

Hypothesis: Mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with MABS will reduce infection burden and improve pulmonary disease.

Objectives:

  1. Efficacy - Assess MABS pulmonary disease response mycobacteriophage therapy
  2. Safety - Determine tolerability and off target effects of IV and inhaled mycobacteriophage therapy

Specific End Points (during and post treatment up to last clinical follow-up (>24month):

  1. Microbiologic: Time to sputum smear and culture conversion; durability of sputum culture conversion during and post treatment; change in sputum microbiology on and post treatment; change in MABS drug and mycobacteriophage susceptibility on and post treatment; mycobacteriophage neutralizing antibody development.
  2. Clinical: Pulmonary and systemic symptom report; sputum production volume (patient report); chest imaging response (CT scan); Spirometry and full PFT; quality of life
  3. Other: Adverse clinical and laboratory events

Information on the Investigational Product (Mycobacteriophage Muddy_HRMN0052):

  1. Mechanism of action Bacteriophage therapy (phage therapy) involves the use of live, lytic bacteriophages to treat bacterial infections via bacterial cell lysis. Lytic bacteriophages mediate their antimicrobial effect by way of specific attachment to bacterial cell wall receptors, injection of bacteriophage DNA into the bacterium, recruitment of bacterial host cell machinery for bacteriophage protein production, and subsequent lysis of the bacterial cell with release of bacteriophage progeny.
  2. Dose, frequency, route of administration for the product

Initial IV dosing of Mycobacteriophage Muddy_HRMN0052 for treatment of Mycobacterium abscessus should be 1mL containing 1 x 10^9 PFU/mL to be given IV twice daily.

Inhalation:

Initial inhaled (by nebulization or aerosolization) dosing of Mycobacteriophage Muddy_HRMN0052 for treatment of Mycobacterium abscessus should be 1mL containing 1 x 10^9 PFU/mL to be given inhaled twice daily. For inhaled use, Mycobacteriophage Muddy_HRMN0052 is supplied in the lyophilized form that enhances the stability during nebulization.

The treatment duration for both routes of administration is expected to be between 16 to 24 weeks at minimum with a possible extension up to 24 months if necessary, based upon clinical response.

Treatment Regimen and Duration:

Initial IV dosing for treatment of Mycobacterium abscessus with Mycobacteriophage Muddy_HRMN0052 should be 1mL containing 1 x 10^9 PFU/mL to be given IV twice daily.

Initial inhaled dosing for treatment of Mycobacterium abscessus with Mycobacteriophage Muddy_HRMN0052 should be 1mL containing 1 x 10^9 PFU/mL to be given inhaled twice daily.

The duration of treatment to be determined based on clinical response, but the recommended initial course of treatment is expected to be at least 16-24 weeks and used together with antimicrobial therapy targeted at the infecting organism recovered from the patient. The duration and start timing of IV and inhaled formulation will be guided by tolerance and clinical response with potential transition to single route as treatment progresses.

If the inhaled route of administration is not tolerated by the patient, as determined by a drop in FEV1 percent predicted (FEV1pp) of greater than 20% from baseline with the first dosage, and/or intolerable symptoms of cough or shortness of breath that are not relieved with bronchodilator (salbutamol) with the first dose, or if respiratory symptoms develop with later dosing that are deemed intolerable by the patient, then the treatment will revert to IV administration.

Concurrent with MUDDY phage treatment the following antibiotics will be use. Use of phage plus antibiotics is similar to prior reported human treatment of NTM disease with mycobacteriophages and in line with Antibacterial Resistance Leadership Group (ARLG) Phage Taskforce (U.S.) guidance. To balance effectiveness and toxicity risk two antibiotics that Mycobacterium abscessus has been demonstrated susceptible to will be used. Selection of drugs is also informed by tolerance during prior treatment. Alternate medications will be used if toxicity from first choice antibiotics encountered. Antibiotics/rationale are as follows, all doses are standard weight-based dosing:

Initial Regimen:

  1. Amikacin 1000mg IV 3x/wk - prior good tolerance, evidence based preferred agent for treatment of NTM disease
  2. Clofazimine 100mg PO OD - prior good tolerance; general low toxicity profile, M. abscessus demonstrated to have favorable low MIC.

Alternate agents (use if toxicity/intolerance to initial regimen agents to ensure on 2 antibiotics throughout):

  1. Bedaquiline 400mg PO OD x 2 weeks then 200mg PO 3x/wk - prior good tolerance; general low toxicity profile, M. abscessus demonstrated to have favorable low MIC.
  2. Linezolid 600mg PO OD (dose reduce to 600mg PO 3x/wk if adverse effects) - unclear if contributed to prior anorexia while on multidrug regimen, risk of toxicity with extended use
  3. Sulfamethoxazole/Trimethoprim 800/160mg PO BID - less evidence available supporting use for M. abscessus disease, prior issues with associated hyperkalemia

AMENDMENT May 30, 2026:

Additional antibiotics to be used guided by follow-up drug susceptibilty testing (stopping medications that may show acquired resistance) and allowing up to 6 potentially effective antibiotic agents may include:

  1. Imipenem 1g IV Q12
  2. Ceftaroline 600mg IV Q12H
  3. Omadacycline 300mg PO BID

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital Non-Tuberculous Mycobacterial Disease Clinic

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

This is an individual patient expanded access study specific to one individual based on tailor intervention (Mycobacteriophage)

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: Mycobacteriophage Muddy_HRMN0052
In-vitro effective Mycobacteriophage Muddy_HRMN0052 against specific strain of Mycobacterium abscessus ssp abscessuss
Drug: Amikacin Injection
Amikacin 1000mg IV 3x/wk
Drug: Clofazimine
Clofazimine 100mg PO OD
Drug: Bedaquiline (B)
Bedaquiline 400mg PO OD x 2 weeks then 200mg PO 3x/wk (Alternate agent if toxicity/intolerance to amikacin or clofazimine to ensure on 2 antibiotics throughout)
Drug: Linezolid (LZD)
Linezolid 600mg PO OD (dose reduce to 600mg PO 3x/wk if adverse effects)(Alternate agent if toxicity/intolerance to amikacin or clofazimine to ensure on 2 antibiotics throughout)
Drug: Sulfamethoxazole/Trimethoprim
Sulfamethoxazole/Trimethoprim 800/160mg PO BID (Alternate agent if toxicity/intolerance to amikacin or clofazimine to ensure on 2 antibiotics throughout)
Drug: Imipenem + Cilastatin
Imipenem 1g IV Q12H
Drug: Ceftaroline fosamil
Ceftaroline 600mg IV Q12H
Drug: Omadacycline Oral Tablet
Omadacycline 300mg PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiologic: Response
Time Frame: 2 years
1. Sputum culture status: time (days) to durable sputum culture conversion (no mycobacterial growth on 3 sputum sample)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiologic: Resistance development
Time Frame: 2 years
MABS drug and phage resistance development on follow-up sputum cultures (on treatment and post)
2 years
Microbiologic: Neutralizing antibody status.
Time Frame: 2 years
Detection of mycobacteriophage neutralizing antibodies on follow-up serology
2 years
Clinical: Symptoms
Time Frame: 2 year
Pulmonary and systemic symptom report change (Physicians Global Assessment to measure quality of life)
2 year
Clinical: Sputum
Time Frame: 2 year
sputum production volume change (patient report)
2 year
Clinical: Radiographic
Time Frame: 2 year
Chest imaging response (CT scan) to treatment
2 year
Clinical: Pulmonary Function
Time Frame: 2 year
Spirometry and full PFT changes on treatment
2 year
Clinical: Adverse effects
Time Frame: 2 year
Adverse clinical and laboratory events (number and severity) on treatment
2 year
Clinical: Symptoms
Time Frame: 2 year

Pulmonary and systemic symptom report change using adapted global assessment of quality of life. This will be patient reported and scored at each clinical assessment as follows and in reference/comparison to last/most recent score (negative = worse, positive = improved):

  • 4 Markedly Improved ( >75% improved quality of life)
  • 3 Much Improved (51-75% improved quality of life)
  • 2 Improved (25-50% improved quality of life)

  • 1 Slightly Improved (1-24% improved quality of life) 0 No Change

    • 1 Slightly Worse (1-24% reduced quality of life)
    • 2 Worse (25-50% reduced quality of life)
    • 3 Much Worse (51-75% reduced quality of life)
    • 4 Markedly Worse (>75 % reduced quality of life)
2 year

Collaborators and Investigators

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

Sponsor

Vancouver Coastal Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 11, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPHAGE-2025-01
  • Control # 300143 (Other Identifier: Health Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will depend on participant and institution agreement

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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