Non - Tuberculosis Mycobacteria Lung Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTGenotype detected through GenSeizer high-throughput gene capture technology
The sputum and/or alveolar lavage fluid of the optimal treatment group was first identified by GenSeizer, which was used to remove the resistant agents and choose the sensitive agents, so as to optimize the initial antimicrobial program. All agents are within the recommended range of 2007 ATS / IDSA Guidelines. All treatment regimens need to be corrected in time according to the final results of culture and in vitro susceptibility testing.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture conversion rate | up to 18 months | The proportion of final sputum conversion to culture negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial time of sputum culture conversion | up to 18 months | The time of first sputum conversion to culture negative |
| Chest CT | up to 18 months | Chest imaging changes of CT examination |
| Blood routine test | every month, up to 18months | — |
| liver function test | every month, up to 18months | — |
| kidney function test | every month, up to 18months | — |
Countries
China
Contacts
Primary ContactHaiqing Chu, PHD
Backup ContactBing Li, PHD
Outcome results
None listed