NCT07429162

Brief Summary

The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.

Trial Health

65
Monitor

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
24mo left

Started Jul 2026

Typical duration for phase_1

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 2, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 2, 2026

Last Update Submit

February 17, 2026

Conditions

Mycobacterium Abscessus InfectionBacteriophage TherapyPulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Time to Sputum Culture Conversion (Microbiologic Response)

    Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment

    1 year

Secondary Outcomes (5)

  • Change in Volume of Sputum Production (Clinical Response)

    1 year

  • Change in frequency of Cough (Clinical Response)

    1 year

  • Change in FEV1 (Clinical Response)

    1 year

  • Change in BMI (Clinical Response)

    1 year

  • Radiographic Response

    1 year

Other Outcomes (1)

  • Adverse Effects (Clinical)

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Use of Mycobacteriophage

Biological: DP-QB-MYA-002

Interventions

DP-QB-MYA-002BIOLOGICAL

In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

MeSH Terms

Conditions

Mycobacterium Infections, NontuberculousLung Diseases

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Pharmacy

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 24, 2026

Study Start (Estimated)

July 2, 2026

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

July 2, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02