NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Shanghai Pulmonary Hospital, Shanghai, China

Status: Unknown

Conditions: Non - Tuberculosis Mycobacteria Lung Disease

Treatments: Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology

Study type: Interventional

Funder types: Other

Identifiers

NCT03224065

K17-144

Details and patient eligibility

About

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.

Enrollment: 246 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Recommended therapy group

No Intervention group

Description:

Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results

Optimized therapy group

Experimental group

Description:

Optimized therapy based on antibiotic resistant genotype test results

Treatment:

Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology