UnknownPhase 4

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

China40 participantsStarted 2022-08-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Treatment Outcome

Timeframe: Treatment period, approximately 12 months.

Trial details

NCT IDNCT05494957

SponsorShanghai Pulmonary Hospital, Shanghai, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-05

Contact for this trial

sha wei

+8602165115006 13671758200@126.com

View on ClinicalTrials.gov More Nontuberculous Mycobacterial Lung Disease trials