NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

NCT ID: NCT03224065

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non - Tuberculosis Mycobacteria Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recommended therapy group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Optimized therapy group

Optimized therapy based on antibiotic resistant genotype test results

Group Type EXPERIMENTAL

Genotype detected through GenSeizer high-throughput gene capture technology

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Haiqng Chu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haiqing Chu

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiqing Chu, PHD

Role: CONTACT

+862165115006 ext. 2112

Bing Li, PHD

Role: CONTACT

+862165115006 ext. 2112

Facility Contacts

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Haiqing Chu

Role: primary

Other Identifiers

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K17-144

Identifier Type: -

Identifier Source: org_study_id

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