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

NCT ID: NCT05494957

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2025-08-05

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.

Conditions

Nontuberculous Mycobacterial Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New treatment regimen including bedaquiline

Treatment regimens that include bedaquiline, linezolid, clofazimine, and other optional drugs.

Group Type: EXPERIMENTAL

New regimen(BdqCfzLzd+XY)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

New regimen for NTM-PD(BdqCfzLzd+XY)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: collaborator

No.85 Hospital, Changning, Shanghai, China

OTHER

Sponsor Role: collaborator

Anhui Chest Hospital

OTHER

Sponsor Role: collaborator

Shanghai Pudong New Area Pulmonary Hospital, China

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Zhengzhou Sixth People's Hospital, China

UNKNOWN

Sponsor Role: collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Wei Sha MD & PhD

Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Countries

China

Central Contacts

sha wei

Role: CONTACT

13671758200@126.com

+8602165115006 ext. 2017

Liu Yidian

Role: CONTACT

13816676933@139.com

+8602165115006 ext. 2017

Other Identifiers

Q20-293

Identifier Type: -

Identifier Source: org_study_id