NCT07228702

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
16mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Oct 2027

First Submitted

Initial submission to the registry

September 9, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

September 9, 2025

Last Update Submit

May 30, 2026

Conditions

Mycobacterium Abscessus InfectionNon-Tuberculous Mycobacterial (NTM) Pneumonia

Keywords

non-tuberculous mycobacteriabacteriophagemycobacteriophagemycobacterium abscessuspulmonary 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

  • +3 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Use of mycobacteriophage

Biological: Mycobacteriophage Muddy_HRMN0052Drug: Amikacin InjectionDrug: ClofazimineDrug: Bedaquiline (B)Drug: Linezolid (LZD)Drug: Sulfamethoxazole/TrimethoprimDrug: Imipenem + CilastatinDrug: Ceftaroline fosamilDrug: Omadacycline Oral Tablet

Interventions

Mycobacteriophage Muddy_HRMN0052BIOLOGICAL

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

Treatment
ClofazimineDRUG

Clofazimine 100mg PO OD

Treatment
Imipenem + CilastatinDRUG

Imipenem 1g IV Q12H

Treatment
Ceftaroline fosamilDRUG

Ceftaroline 600mg IV Q12H

Treatment
Omadacycline Oral TabletDRUG

Omadacycline 300mg PO BID

Treatment
Amikacin InjectionDRUG

Amikacin 1000mg IV 3x/wk

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/TrimethoprimDRUG

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

Treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • consent to participation

You may not qualify if:

  • non-consent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 28329182BACKGROUND

  • 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: 36583829BACKGROUND

  • 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: 35676823BACKGROUND

MeSH Terms

Conditions

PneumoniaMycobacterium Infections, NontuberculousLung Diseases

Interventions

AmikacinClofaziminebedaquilineLinezolidTrimethoprim, Sulfamethoxazole Drug CombinationCilastatin, Imipenem Drug CombinationCeftarolineomadacycline

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRespiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

KanamycinAminoglycosidesGlycosidesCarbohydratesPhenazinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingSulfamethoxazoleBenzenesulfonamidesSulfonamidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesDrug CombinationsPharmaceutical PreparationsImipenemThienamycinsCarbapenemsbeta-LactamsLactamsCilastatinCyclopropanesCycloparaffinsHydrocarbons, AlicyclicHeterocyclic Compounds, 2-RingFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsCephalosporinsThiazines

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

January 11, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations

CA(1)