NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Conditions
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Non - Tuberculosis Mycobacteria Lung Disease

Intervention / Treatment
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* Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Recommended therapy group<br>Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results | |
| Experimental: Optimized therapy group<br>Optimized therapy based on antibiotic resistant genotype test results | Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture conversion rate | The proportion of final sputum conversion to culture negative | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial time of sputum culture conversion | The time of first sputum conversion to culture negative | up to 18 months | 
| Chest CT | Chest imaging changes of CT examination | up to 18 months | 
| Blood routine test |  | every month, up to 18months | 
| liver function test |  | every month, up to 18months | 
| kidney function test |  | every month, up to 18months |