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

NCT05494957 | Unknown Phase 4

• 1 other identifier: Q20-293
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nontuberculous Mycobacterial Lung Disease

Keywords

Nontuberculous Mycobacterial Lung Disease; bedaquiline; Clofazimine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement rate of imaging

  Treatment period, approximately 12 months.

Other Outcomes (3)

• Improvement in lung function

  Treatment period, approximately 12 months.

• Adverse Events

  Treatment period, approximately 12 months.

• Mycobacterial culture negative conversion rate

  Treatment period, approximately 12 months.

Study Arms (1)

New treatment regimen including bedaquiline

EXPERIMENTAL

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

Drug: New regimen(BdqCfzLzd+XY)

Interventions

New regimen(BdqCfzLzd+XY) 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.

Also known as: New regimen for NTM-PD(BdqCfzLzd+XY)

New treatment regimen including bedaquiline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Proposed anti-NTM therapy based on current disease.
• Patients aged 18 to 65 years.
• able to understand and have signed an informed consent form.
• culture drug sensitivity results showing resistance to clarithromycin; or previous anti-NTM therapy has been ineffective.
• 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.

You may not qualify if:

• History of allergy to any drug in the protocol
• Combined hepatic, renal, metabolic, autoimmune diseases, endocrine, hematological, neurological diseases, psychiatric disorders, malignancies, long-term immunosuppressive drugs or HIV/AIDS patients
• QTc interval \>470 ms in women and \>450 ms in men
• Severe pulmonary hypoplasia (FEV \<30%)
• Those with co-infection with other Mycobacterium species
• Pregnant or breastfeeding females.
• Those who are also participating in other clinical studies.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Shanghai Public Health Clinical Center: collaborator
• No.85 Hospital, Changning, Shanghai, China: collaborator
• Anhui Chest Hospital: collaborator
• Shanghai Pudong New Area Pulmonary Hospital, China: collaborator
• Huashan Hospital: collaborator
• Zhengzhou Sixth People's Hospital, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

Central Study Contacts

sha wei

CONTACT

+8602165115006; 13671758200@126.com

Liu Yidian

CONTACT

+8602165115006; 13816676933@139.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor

Model Details: Treatment regimens containing bedaquiline, linezolid, clofazimine, and other drugs

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: August 5, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2025
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)