NCT03224065

NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non - Tuberculosis Mycobacteria Lung Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Genotype 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.

Timeline

• Start date: 2017-10-09
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2017-07-21
• Last updated: 2019-09-18

Locations

1 site across 1 country: China