Overview

Clinical Study of New Intensive Treatment Regimen for Severe Nontuberculous Mycobacterial Pulmonary Disease

Status:
Not yet recruiting
Trial end date:
2025-08-05
Target enrollment:
0
Participant gender:
All
Summary
Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Collaborators:
Anhui Chest Hospital
Huashan Hospital
No.85 Hospital, Changning, Shanghai, China
Shanghai Public Health Clinical Center
Shanghai Pudong New Area Pulmonary Hospital, China
Zhengzhou Sixth People's Hospital, China
Criteria
Inclusion Criteria:

1. Patients with non-tuberculous mycobacterial lung disease who meet the diagnostic
criteria of the American Thoracic Society and British Thoracic Society guidelines or
the Chinese Expert Consensus on the Diagnosis and Treatment of Non-tuberculous
Mycobacteriosis (2020) and whose strain is identified as Mycobacterium
intracellulare/abscessus

2. Proposed anti-NTM therapy based on current disease.

3. Patients aged 18 to 65 years.

4. able to understand and have signed an informed consent form.

5. culture drug sensitivity results showing resistance to clarithromycin; or previous
anti-NTM therapy has been ineffective.

6. Patients with severe NTM lung disease, with chest CT showing greater than 50% of the
extent of infection lesions in both lungs; or with short-term progressive worsening of
the disease.

Exclusion Criteria:

1. History of allergy to any drug in the protocol

2. Combined hepatic, renal, metabolic, autoimmune diseases, endocrine, hematological,
neurological diseases, psychiatric disorders, malignancies, long-term
immunosuppressive drugs or HIV/AIDS patients

3. QTc interval >470 ms in women and >450 ms in men

4. Severe pulmonary hypoplasia (FEV <30%)

5. Those with co-infection with other Mycobacterium species

6. Pregnant or breastfeeding females.

7. Those who are also participating in other clinical studies.