Bacteriophage Therapy for Mycobacterium Abscessus Infection

Age: Any Age

Sex: Female

Trial Phase: Phase 1

Sponsor: Vancouver Coastal Health

Disqualifiers: Non-consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Mycobacteriophage Muddy_HRMN0052, a type of bacteriophage therapy, for lung infections caused by Mycobacterium abscessus. The goal is to determine if this treatment, combined with standard medications, can reduce the infection and improve lung health. This trial is specifically designed for one individual who has agreed to participate. As a Phase 1 trial, the research focuses on understanding how the treatment works in humans, offering the participant the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

Is there any evidence suggesting that Mycobacteriophage Muddy_HRMN0052 is likely to be safe for humans?

Research shows that Mycobacteriophage Muddy_HRMN0052 is being explored as a potential treatment for lung infections caused by Mycobacterium abscessus. This treatment, known as phage therapy, uses viruses to target and destroy bacteria. As a new approach, earlier studies have found that phages can reduce bacteria levels inside cells, offering promise for treating difficult infections.

While limited safety data for humans exists, the treatment's presence in an early-phase trial indicates that its safety is under careful study. This typically suggests the treatment is considered potentially safe enough for initial human testing, though more information is needed for confirmation. Participants in these trials receive close monitoring for any side effects. Prospective participants should discuss any concerns with the research team, who can provide more personalized information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Mycobacterium abscessus infections, which typically involve antibiotics, the mycobacteriophage Muddy_HRMN0052 uses a completely different approach by employing bacteriophages—viruses that specifically target and destroy bacteria. Researchers are excited about this treatment because it offers a targeted mechanism of action that can potentially overcome antibiotic resistance, a common issue with current therapies. Additionally, bacteriophage therapy may result in fewer side effects compared to the broad-spectrum antibiotics currently used, making it a promising alternative for patients with this challenging condition.

What evidence suggests that Mycobacteriophage Muddy_HRMN0052 might be an effective treatment for Mycobacterium abscessus infection?

Research has shown that Mycobacteriophage Muddy_HRMN0052 works effectively in the lab against Mycobacterium abscessus, a bacteria often difficult to treat. One study successfully used it to treat a 15-year-old lung transplant patient with this infection. Another report described 20 cases where phage therapy benefited at least five patients with Mycobacterium infections, without harmful side effects. Additionally, lab tests have demonstrated that phage treatment greatly reduces the bacteria inside cells. These findings suggest that Mycobacteriophage Muddy_HRMN0052, which participants in this trial will receive, could be a promising option for reducing infection in people with this challenging lung disease. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with a lung infection caused by Mycobacterium abscessus, which can lead to conditions like atypical mycobacterial infection and pneumonia. Participants must consent to join the study.

Inclusion Criteria

I agree to participate in the study.

Exclusion Criteria

I do not agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mycobacteriophage Muddy_HRMN0052 therapy via IV and inhalation, along with combination conventional antimycobacterial therapy

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sputum culture conversion and symptom assessment

24 months

Extension

Potential extension of treatment up to 24 months based on clinical response

What Are the Treatments Tested in This Trial?

Interventions

• Mycobacteriophage Muddy_HRMN0052

Trial Overview The study tests a combination of conventional antibiotics (Sulfamethoxazole/Trimethoprim, Amikacin Injection, Linezolid, Clofazimine, Bedaquiline) with a special virus called Mycobacteriophage Muddy_HRMN0052 that targets bacteria to treat lung infections.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 6 Interventions

Use of mycobacteriophage

Who Is Running the Clinical Trial?

Vancouver Coastal Health

Lead Sponsor

Trials

41

Recruited

717,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07228702?aggFilters=status%3A%2Cphase%3A

Bacteriophage Therapy for Mycobacterium Abscessus ... In-vitro effective Mycobacteriophage Muddy_HRMN0052 against specific strain of Mycobacterium abscessus ssp abscessuss. Drug : Amikacin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7999966/

Phage Therapy for Mycobacterium Abscessus and Strategies ... In 2019, Dedrick et al. [25] reported the successful treatment of a 15-year-old lung-transplant patient who suffered from disseminated M.

3. academic.oup.com academic.oup.com/cid/article/76/1/103/6604409

Compassionate Use of Phages in 20 Patients With Drug ... We describe 20 consecutive cases of bacteriophage treatment of Mycobacterium infections. We observed no adverse reactions, favorable outcomes in at least 5.

4. journals.asm.org journals.asm.org/doi/10.1128/mbio.02924-23

Bacteriophage infection and killing of intracellular ... We show that phage treatment can significantly reduce the intracellular burden of M. abscessus in a manner that depends on both the specific phage and ...

5. nature.com nature.com/articles/s42003-024-06006-x

Bacteriophage therapy for the treatment of Mycobacterium ... In this study, we show that bacteriophage strains D29 and DS6A can efficiently lyse Mtb H37Rv in 7H10 agar plates. However, only phage DS6A efficiently kills H ...

6. journals.asm.org journals.asm.org/doi/pdf/10.1128/spectrum.02277-25?download=true

Amplification, purification, and lyophilization of ... Here, we describe the detailed methods we have used to grow mycobacteriophages to high titers, to concentrate and purify them so that they are ...

7. canada.ca canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment/mycobacterium.html

Mycobacterium spp. - Pathogen Safety Data Sheets PHYSICAL INACTIVATION: Mycobacteria are easily inactivated by heat (> 65 °C for at least 30 min) and by UV light but not by freezing or desiccation. SURVIVAL ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790704/

Bacteriophage infection and killing of intracellular ... - PMC - NIH We show that phage treatment can significantly reduce the intracellular burden of M. abscessus in a manner that depends on both the specific phage and ...

9. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2020.609017/epub

Considerations for Phage Therapy Against Mycobacterium ... There is a global increasing number of Mycobacterium abscessus infections, especially pulmonary infections. Reduced therapeutic options ...