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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Use of Mycobacteriophage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DP-QB-MYA-002 | Biological | In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sputum Culture Conversion (Microbiologic Response) | Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Volume of Sputum Production (Clinical Response) | Patient Report | 1 year |
| Change in frequency of Cough (Clinical Response) | Patient Report |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects (Clinical) | Adverse clinical and laboratory events (number and severity) on treatment | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| 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. | 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. | 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. | 1 year |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |