Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

NCT07228702 | Enrolling By Invitation Phase 1

• 2 other identifiers: MPHAGE-2025-01Control # 300143
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection

Keywords

non-tuberculous mycobacteria; bacteriophage; mycobacteriophage; mycobacterium abscessus; pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Microbiologic: Response

  1\. Sputum culture status: time (days) to durable sputum culture conversion (no mycobacterial growth on 3 sputum sample)

  2 years

Secondary Outcomes (8)

• Microbiologic: Resistance development

  2 years

• Microbiologic: Neutralizing antibody status.

  2 years

• Clinical: Symptoms

  2 year

• Clinical: Sputum

  2 year

• Clinical: Radiographic

  2 year

Study Arms (1)

Treatment

EXPERIMENTAL

Use of mycobacteriophage

Biological: Mycobacteriophage Muddy_HRMN0052; Drug: Amikacin Injection; Drug: Clofazimine; Drug: Bedaquiline (B); Drug: Linezolid (LZD); Drug: Sulfamethoxazole/Trimethoprim

Interventions

Mycobacteriophage Muddy_HRMN0052 BIOLOGICAL

In-vitro effective Mycobacteriophage Muddy\_HRMN0052 against specific strain of Mycobacterium abscessus ssp abscessuss

Treatment

Amikacin Injection DRUG

Amikacin 1000mg IV 3x/wk

Treatment

Clofazimine DRUG

Clofazimine 100mg PO OD

Treatment

Bedaquiline (B) DRUG

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)

Treatment

Linezolid (LZD) DRUG

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)

Treatment

Sulfamethoxazole/Trimethoprim DRUG

Sulfamethoxazole/Trimethoprim 800/160mg PO BID (Alternate agent if toxicity/intolerance to amikacin or clofazimine to ensure on 2 antibiotics throughout)

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• consent to participation

You may not qualify if:

• non-consent to participation

Sponsors & Collaborators

• Vancouver Coastal Health: lead

Study Sites (1)

Vancouver General Hospital Non-Tuberculous Mycobacterial Disease Clinic

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (3)

• Reindel R, Fiore CR. Phage Therapy: Considerations and Challenges for Development. Clin Infect Dis. 2017 Jun 1;64(11):1589-1590. doi: 10.1093/cid/cix188. No abstract available.

  PMID: 28329182 BACKGROUND

• Hatfull GF. Phage Therapy for Nontuberculous Mycobacteria: Challenges and Opportunities. Pulm Ther. 2023 Mar;9(1):91-107. doi: 10.1007/s41030-022-00210-y. Epub 2022 Dec 30.

  PMID: 36583829 BACKGROUND

• Dedrick RM, Smith BE, Cristinziano M, Freeman KG, Jacobs-Sera D, Belessis Y, Whitney Brown A, Cohen KA, Davidson RM, van Duin D, Gainey A, Garcia CB, Robert George CR, Haidar G, Ip W, Iredell J, Khatami A, Little JS, Malmivaara K, McMullan BJ, Michalik DE, Moscatelli A, Nick JA, Tupayachi Ortiz MG, Polenakovik HM, Robinson PD, Skurnik M, Solomon DA, Soothill J, Spencer H, Wark P, Worth A, Schooley RT, Benson CA, Hatfull GF. Phage Therapy of Mycobacterium Infections: Compassionate Use of Phages in 20 Patients With Drug-Resistant Mycobacterial Disease. Clin Infect Dis. 2023 Jan 6;76(1):103-112. doi: 10.1093/cid/ciac453.

  PMID: 35676823 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Mycobacterium Infections, Nontuberculous; Lung Diseases

Interventions

Amikacin; Clofazimine; bedaquiline; Linezolid; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Phenazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: November 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CA (1)