NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Not Applicable

• Conditions: Non - Tuberculosis Mycobacteria Lung Disease
• Interventions: Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology

• Registration Number: NCT03224065
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2017-10-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimized therapy group	Genotype detected through GenSeizer high-throughput gene capture technology	Optimized therapy based on antibiotic resistant genotype test results

Primary Outcome Measures

Name	Time	Method
Culture conversion rate	up to 18 months	The proportion of final sputum conversion to culture negative

Secondary Outcome Measures

Name	Time	Method
Blood routine test	every month, up to 18months
Initial time of sputum culture conversion	up to 18 months	The time of first sputum conversion to culture negative
liver function test	every month, up to 18months
kidney function test	every month, up to 18months
Chest CT	up to 18 months	Chest imaging changes of CT examination

Trial Locations

Locations (1)

Haiqing Chu; 🇨🇳 Shanghai, China