Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
NCT07228702 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2025-11-17
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
Interventions
- 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)
Sponsors & Collaborators
-
Vancouver Coastal Health
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-30
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
Countries
- Canada
Study Locations
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