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

Phase 4

Not yet recruiting

• Conditions: Nontuberculous Mycobacterial Lung Disease
• Interventions: Drug: New regimen(BdqCfzLzd+XY)

• Registration Number: NCT05494957
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-05
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2024-08-05
• Study Completion: 2025-08-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New treatment regimen including bedaquiline	New regimen(BdqCfzLzd+XY)	Treatment regimens that include bedaquiline, linezolid, clofazimine, and other optional drugs.

Primary Outcome Measures

Name	Time	Method
Treatment Outcome	Treatment period, approximately 12 months.	Evaluation of treatment outcome at completion of treatment: can be classified as bacteriologically negative; bacteriologically cured; clinically cured; cured; treatment failure; bacteriological relapse; death.

Secondary Outcome Measures

Name	Time	Method
Improvement rate of imaging	Treatment period, approximately 12 months.	Changes in imaging aspects of completed treatment compared to baseline can be classified as: absorption, significant absorption, no change, deterioration

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China