Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03224065
Other study ID # K17-144
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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