Non - Tuberculosis Mycobacteria Lung Disease Clinical Trial
Official title:
Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of clinical studies. More and more studies have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41), rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of guideline recommended therapy and optimized therapy according to antibiotic susceptibility - related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene capture technique.
Status | Recruiting |
Enrollment | 246 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007 - non-CF Bronchiectasis Exclusion Criteria: - Already on treatment for NTM lung disease - Appropriate exclusion of other lung diagnosis - Patients with severe organ dysfunction |
Country | Name | City | State |
---|---|---|---|
China | Haiqing Chu | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pulmonary Hospital, Shanghai, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Culture conversion rate | The proportion of final sputum conversion to culture negative | up to 18 months | |
Secondary | Initial time of sputum culture conversion | The time of first sputum conversion to culture negative | up to 18 months | |
Secondary | Chest CT | Chest imaging changes of CT examination | up to 18 months | |
Secondary | Blood routine test | every month, up to 18months | ||
Secondary | liver function test | every month, up to 18months | ||
Secondary | kidney function test | every month, up to 18months |