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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss
Time to Sputum Culture Conversion (Microbiologic Response)
Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment
Time frame: 1 year
Change in Volume of Sputum Production (Clinical Response)
Patient Report
Time frame: 1 year
Change in frequency of Cough (Clinical Response)
Patient Report
Time frame: 1 year
Change in FEV1 (Clinical Response)
This will be assessed via spirometry at baseline and at the end of the study An increase in FEV1 indicating improvement in lung function or FEV1 decrease indicating decline in lung function.
Time frame: 1 year
Change in BMI (Clinical Response)
Within subject change in BMI measured in kg/m\^2. Increase in BMI as a sign of improvement. Decline in BMI as sign of decline or worse outcome.
Time frame: 1 year
Radiographic Response
Chest imaging response (CT scan) to treatment. Reduction in size, number or density of pulmonary nodules indicating improvement, whereas increased size, number or density indicating worsening.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.