Non - Tuberculosis Mycobacteria Lung DiseaseNCT03224065
NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy
A study testing Genotype detected through GenSeizer high-throughput gene capture technology in people with Non - Tuberculosis Mycobacteria Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Non - Tuberculosis Mycobacteria Lung Disease
- What is being tested?
- Genotype detected through GenSeizer high-throughput gene capture technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
- non-CF Bronchiectasis
Who cannot join
- Already on treatment for NTM lung disease
- Appropriate exclusion of other lung diagnosis
- Patients with severe organ dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Haiqing Chu
Shanghai
Haiqing Chu, chu_haiqing@126.com
About this study
Official title: 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.
- Being tested
- Genotype detected through GenSeizer high-throughput gene capture technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotype detected through GenSeizer high-throughput gene capture technologyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Recommended therapy group | No intervention | Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results |
| Optimized therapy group | Experimental | Optimized therapy based on antibiotic resistant genotype test results Receives: Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture conversion rate
The proportion of final sputum conversion to culture negative
Measured: up to 18 months
Secondary outcomes (5)
Initial time of sputum culture conversion
The time of first sputum conversion to culture negative
Measured: up to 18 months
Chest CT
Chest imaging changes of CT examination
Measured: up to 18 months
Blood routine test
Measured: every month, up to 18months
liver function test
Measured: every month, up to 18months
kidney function test
Measured: every month, up to 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start9 Oct 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non - Tuberculosis Mycobacteria Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiqng Chu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224065
- Sponsor's protocol ID
- K17-144
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy
- ClinicalTrials.gov ID
- NCT03224065
- Acronym / sponsor ID
- K17-144
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended therapy group | No intervention | –Guideline recommended regimen for treatment, regardless of antibiotic resistant genotype test results |
| Optimized therapy group | Experimental | Diagnostic Test: Genotype detected through GenSeizer high-throughput gene capture technologyOptimized therapy based on antibiotic resistant genotype test results |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
- non-CF Bronchiectasis
Key exclusion criteria (3 listed)
- Already on treatment for NTM lung disease
- Appropriate exclusion of other lung diagnosis
- Patients with severe organ dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotype detected through GenSeizer high-throughput gene capture technologyThe 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. | Diagnostic test | Optimized therapy group |
Primary outcome
Culture conversion rate
Time frame: up to 18 months
The proportion of final sputum conversion to culture negative
5 secondary outcomes
Initial time of sputum culture conversion
Time frame: up to 18 months
Chest CT
Time frame: up to 18 months
Blood routine test
Time frame: every month, up to 18months
liver function test
Time frame: every month, up to 18months
kidney function test
Time frame: every month, up to 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genotype detected through GenSeizer high-throughput gene capture technology in people with Non - Tuberculosis Mycobacteria Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiqing Chu, PHD (+862165115006 ext. 2112, chu_haiqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture conversion rate (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.