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

Nontuberculous Mycobacterial Lung Disease Clinical Trial

— NTM-PD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05494957
• Other study ID #: Q20-293
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 5, 2022
• Est. completion date: August 5, 2025

Study information

• Verified date: August 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: sha wei
• Phone: +8602165115006
• Email: 13671758200[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Currently, the annual prevalence of nontuberculous mycobacterial lung disease is increasing year by year. the clinical presentation of NTM is similar to that of tuberculosis, but most NTM is severely resistant to antibiotics, making it difficult to treat, and it responds poorly to classical antituberculous mycobacterial drugs. the overall response rate for the treatment of NTM lung disease is approximately 50% according to current domestic and international treatment guidelines. In severe NTM lung disease, after more than one anti-mycobacterial treatment, the resistance rate is even higher, the disease is more severe, and treatment is even more difficult. Current clinical treatment regimens are mainly long courses and combinations of drugs, however, the results are often unsatisfactory with an overall cure rate of only 30%. Therefore, we need to continue to explore new effective drugs for NTM lung disease and explore new and more effective drug regimens.

Several drugs have shown promising effects in basic research and clinical applications for NTM. For example, clofazimine has shown good efficacy in the treatment of nontuberculous mycobacterial lung disease. In addition, some new antibiotics or anti-tuberculosis drugs have attracted attention for showing good anti-NTM effects in in vitro experiments, such as tigecycline, linezolid, and bedaquiline. Based on the clinical experience of the investigators and related basic research, we conducted a clinical study of new regimens for intensive treatment of severe non-tuberculous mycobacterial lung disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 5, 2025
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Nontuberculous Mycobacterial Lung Disease

Intervention

Drug:
• New regimen(BdqCfzLzd+XY)
The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history and in vitro culture drug sensitivity results to form the regimen, and the treatment period is usually more than 12 months, and the doses of various drugs are used for the regular drug use.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in lung function	Improvement of lung function FEV1 after treatment compared to baseline.	Treatment period, approximately 12 months.
Other	Adverse Events	Adverse Events that occurred during the study: Grade 3 or higher adverse reactions during treatment, or significant abnormalities in vital signs.	Treatment period, approximately 12 months.
Other	Mycobacterial culture negative conversion rate	Mycobacterial culture negative conversion rate at the end of the treatment course compared to baseline	Treatment period, approximately 12 months.
Primary	Treatment Outcome	Evaluation of treatment outcome at completion of treatment: can be classified as bacteriologically negative; bacteriologically cured; clinically cured; cured; treatment failure; bacteriological relapse; death.	Treatment period, approximately 12 months.
Secondary	Improvement rate of imaging	Changes in imaging aspects of completed treatment compared to baseline can be classified as: absorption, significant absorption, no change, deterioration	Treatment period, approximately 12 months.