Nontuberculous Mycobacterial Lung DiseasePhase 4NTM-PDNCT05494957
Clinical Study of New Intensive Treatment Regimen for Severe Nontuberculous Mycobacterial Pulmonary Disease
A Phase 4 study testing New regimen(BdqCfzLzd+XY) in people with Nontuberculous Mycobacterial Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nontuberculous Mycobacterial Lung Disease
- What is being tested?
- New regimen(BdqCfzLzd+XY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2022to 5 Aug 2025
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-tuberculous mycobacterial lung disease who meet the diagnostic criteria of the American Thoracic Society and British Thoracic Society guidelines or the Chinese Expert Consensus on the Diagnosis and Treatment of Non-tuberculous Mycobacteriosis (2020) and whose strain is identified as Mycobacterium intracellulare/abscessus
- Proposed anti-NTM therapy based on current disease.
- Patients aged 18 to 65 years.
- able to understand and have signed an informed consent form.
- culture drug sensitivity results showing resistance to clarithromycin; or previous anti-NTM therapy has been ineffective.
- Patients with severe NTM lung disease, with chest CT showing greater than 50% of the extent of infection lesions in both lungs; or with short-term progressive worsening of the disease.
Who cannot join
- History of allergy to any drug in the protocol
- Combined hepatic, renal, metabolic, autoimmune diseases, endocrine, hematological, neurological diseases, psychiatric disorders, malignancies, long-term immunosuppressive drugs or HIV/AIDS patients
- QTc interval >470 ms in women and >450 ms in men
- Severe pulmonary hypoplasia (FEV <30%)
- Those with co-infection with other Mycobacterium species
- Pregnant or breastfeeding females.
- Those who are also participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease.
Read the detailed description
Currently, the annual prevalence of nontuberculous mycobacterial lung disease is increasing year by year. the clinical presentation of NTM is similar to that of tuberculosis, but most NTM is severely resistant to antibiotics, making it difficult to treat, and it responds poorly to classical antituberculous mycobacterial drugs. the overall response rate for the treatment of NTM lung disease is approximately 50% according to current domestic and international treatment guidelines. In severe NTM lung disease, after more than one anti-mycobacterial treatment, the resistance rate is even higher, the disease is more severe, and treatment is even more difficult. Current clinical treatment regimens are mainly long courses and combinations of drugs, however, the results are often unsatisfactory with an overall cure rate of only 30%. Therefore, we need to continue to explore new effective drugs for NTM lung disease and explore new and more effective drug regimens.
Several drugs have shown promising effects in basic research and clinical applications for NTM. For example, clofazimine has shown good efficacy in the treatment of nontuberculous mycobacterial lung disease. In addition, some new antibiotics or anti-tuberculosis drugs have attracted attention for showing good anti-NTM effects in in vitro experiments, such as tigecycline, linezolid, and bedaquiline. Based on the clinical experience of the investigators and related basic research, we conducted a clinical study of new regimens for intensive treatment of severe non-tuberculous mycobacterial lung disease.
- Being tested
- New regimen(BdqCfzLzd+XY)
- Keywords
- Nontuberculous Mycobacterial Lung Disease, bedaquiline, Clofazimine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New regimen(BdqCfzLzd+XY)Drug
Also called New regimen for NTM-PD(BdqCfzLzd+XY)
The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history and in vitro culture drug sensitivity results to form the regimen, and the treatment period is usually more than 12 months, and the doses of various drugs are used for the regular drug use.
| Study group | Role | What they receive |
|---|---|---|
| New treatment regimen including bedaquiline | Experimental | Treatment regimens that include bedaquiline, linezolid, clofazimine, and other optional drugs. Receives: Drug: New regimen(BdqCfzLzd+XY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Outcome
Evaluation of treatment outcome at completion of treatment: can be classified as bacteriologically negative; bacteriologically cured; clinically cured; cured; treatment failure; bacteriological relapse; death.
Measured: Treatment period, approximately 12 months.
Secondary outcomes (1)
Improvement rate of imaging
Changes in imaging aspects of completed treatment compared to baseline can be classified as: absorption, significant absorption, no change, deterioration
Measured: Treatment period, approximately 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start5 Aug 2022 (estimated)
- Primary completion5 Aug 2024 (estimated)
- Study completion5 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment regimens containing bedaquiline, linezolid, clofazimine, and other drugs
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Public Health Clinical Center, No.85 Hospital, Changning, Shanghai, China, Anhui Chest Hospital, Shanghai Pudong New Area Pulmonary Hospital, China, Huashan Hospital, The Sixth People's Hospital of Zhengzhou
- Responsible party
- Principal investigator, Wei Sha MD & PhD, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494957
- Sponsor's protocol ID
- Q20-293
- Acronym
- NTM-PD
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of New Intensive Treatment Regimen for Severe Nontuberculous Mycobacterial Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05494957
- Acronym / sponsor ID
- NTM-PD / Q20-293
- Keywords
- Nontuberculous Mycobacterial Lung Disease, bedaquiline, Clofazimine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Public Health Clinical Center, No.85 Hospital, Changning, Shanghai, China, Anhui Chest Hospital, Shanghai Pudong New Area Pulmonary Hospital, China, Huashan Hospital, The Sixth People's Hospital of Zhengzhou
- Study start
- 5 Aug 2022 (estimated)
- Primary completion
- 5 Aug 2024 (estimated)
- Study completion
- 5 Aug 2025 (estimated)
- First posted
- 10 Aug 2022 (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.
Investigators have selected a number of new drugs, including bedaquiline, to form a regimen to conduct clinical studies for the treatment of severe NTM lung disease.
Detailed description
Currently, the annual prevalence of nontuberculous mycobacterial lung disease is increasing year by year. the clinical presentation of NTM is similar to that of tuberculosis, but most NTM is severely resistant to antibiotics, making it difficult to treat, and it responds poorly to classical antituberculous mycobacterial drugs. the overall response rate for the treatment of NTM lung disease is approximately 50% according to current domestic and international treatment guidelines. In severe NTM lung disease, after more than one anti-mycobacterial treatment, the resistance rate is even higher, the disease is more severe, and treatment is even more difficult. Current clinical treatment regimens are mainly long courses and combinations of drugs, however, the results are often unsatisfactory with an overall cure rate of only 30%. Therefore, we need to continue to explore new effective drugs for NTM lung disease and explore new and more effective drug regimens.
Several drugs have shown promising effects in basic research and clinical applications for NTM. For example, clofazimine has shown good efficacy in the treatment of nontuberculous mycobacterial lung disease. In addition, some new antibiotics or anti-tuberculosis drugs have attracted attention for showing good anti-NTM effects in in vitro experiments, such as tigecycline, linezolid, and bedaquiline. Based on the clinical experience of the investigators and related basic research, we conducted a clinical study of new regimens for intensive treatment of severe non-tuberculous mycobacterial lung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment regimens containing bedaquiline, linezolid, clofazimine, and other drugs
| Arm | Type | Receives |
|---|---|---|
| New treatment regimen including bedaquiline | Experimental | Drug: New regimen(BdqCfzLzd+XY)Treatment regimens that include bedaquiline, linezolid, clofazimine, and other optional drugs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-tuberculous mycobacterial lung disease who meet the diagnostic criteria of the American Thoracic Society and British Thoracic Society guidelines or the Chinese Expert Consensus on the Diagnosis and Treatment of Non-tuberculous Mycobacteriosis (2020) and whose strain is identified as Mycobacterium intracellulare/abscessus
- Proposed anti-NTM therapy based on current disease.
- Patients aged 18 to 65 years.
- able to understand and have signed an informed consent form.
- culture drug sensitivity results showing resistance to clarithromycin; or previous anti-NTM therapy has been ineffective.
Key exclusion criteria (7 listed)
- History of allergy to any drug in the protocol
- Combined hepatic, renal, metabolic, autoimmune diseases, endocrine, hematological, neurological diseases, psychiatric disorders, malignancies, long-term immunosuppressive drugs or HIV/AIDS patients
- QTc interval >470 ms in women and >450 ms in men
- Severe pulmonary hypoplasia (FEV <30%)
- Those with co-infection with other Mycobacterium species
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 |
|---|---|---|
| New regimen(BdqCfzLzd+XY)Also: New regimen for NTM-PD(BdqCfzLzd+XY)The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history and in vitro culture drug sensitivity results to form the regimen, and the treatment period is usually more than 12 months, and the doses of various drugs are used for the regular drug use. | Drug | New treatment regimen including bedaquiline |
Primary outcome
Treatment Outcome
Time frame: Treatment period, approximately 12 months.
Evaluation of treatment outcome at completion of treatment: can be classified as bacteriologically negative; bacteriologically cured; clinically cured; cured; treatment failure; bacteriological relapse; death.
1 secondary outcome
Improvement rate of imaging
Time frame: Treatment period, approximately 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing New regimen(BdqCfzLzd+XY) in people with Nontuberculous Mycobacterial 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 6 inclusion and 7 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 10 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sha wei (+8602165115006 ext. 2017, 13671758200@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Outcome (time frame: Treatment period, approximately 12 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 10 Aug 2022.