NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Non - Tuberculosis Mycobacteria Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03224065
• Other study ID #: K17-144
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2019
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Haiqing Chu, PHD
• Phone: +862165115006
• Email: chu_haiqing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Infections
• Non - Tuberculosis Mycobacteria Lung Disease
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
China	Haiqing Chu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture conversion rate	The proportion of final sputum conversion to culture negative	up to 18 months
Secondary	Initial time of sputum culture conversion	The time of first sputum conversion to culture negative	up to 18 months
Secondary	Chest CT	Chest imaging changes of CT examination	up to 18 months
Secondary	Blood routine test		every month, up to 18months
Secondary	liver function test		every month, up to 18months
Secondary	kidney function test		every month, up to 18months