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NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Primary Purpose

Non - Tuberculosis Mycobacteria Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Genotype detected through GenSeizer high-throughput gene capture technology
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non - Tuberculosis Mycobacteria Lung Disease

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haiqing ChuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Recommended therapy group

Optimized therapy group

Arm Description

Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results

Optimized therapy based on antibiotic resistant genotype test results

Outcomes

Primary Outcome Measures

Culture conversion rate
The proportion of final sputum conversion to culture negative

Secondary Outcome Measures

Initial time of sputum culture conversion
The time of first sputum conversion to culture negative
Chest CT
Chest imaging changes of CT examination
Blood routine test
liver function test
kidney function test

Full Information

First Posted
July 16, 2017
Last Updated
September 17, 2019
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03224065
Brief Title
NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Official Title
Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non - Tuberculosis Mycobacteria Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recommended therapy group
Arm Type
No Intervention
Arm Description
Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results
Arm Title
Optimized therapy group
Arm Type
Experimental
Arm Description
Optimized therapy based on antibiotic resistant genotype test results
Intervention Type
Diagnostic Test
Intervention Name(s)
Genotype detected through GenSeizer high-throughput gene capture technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Culture conversion rate
Description
The proportion of final sputum conversion to culture negative
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Initial time of sputum culture conversion
Description
The time of first sputum conversion to culture negative
Time Frame
up to 18 months
Title
Chest CT
Description
Chest imaging changes of CT examination
Time Frame
up to 18 months
Title
Blood routine test
Time Frame
every month, up to 18months
Title
liver function test
Time Frame
every month, up to 18months
Title
kidney function test
Time Frame
every month, up to 18months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiqing Chu, PHD
Phone
+862165115006
Ext
2112
Email
chu_haiqing@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Li, PHD
Phone
+862165115006
Ext
2112
Email
libing044162@163.com
Facility Information:
Facility Name
Haiqing Chu
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiqing Chu
Email
chu_haiqing@126.com

12. IPD Sharing Statement

Learn more about this trial

NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

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