NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

September 17, 2019 updated by: Haiqng Chu, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Recommended therapy group
Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results
Experimental: Optimized therapy group
Optimized therapy based on antibiotic resistant genotype test results
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culture conversion rate
Time Frame: up to 18 months
The proportion of final sputum conversion to culture negative
up to 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2017

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

July 16, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K17-144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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