To Investigate the Inflammasome Response of Inflammatory and Resting MacrophageNCT02005094
The Role of Inflammasome in Inflammatory Macrophage in Mycobacterium Avium Complex-lung Disease and Mycobacterium Abscessus-lung Disease
An observational study of To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage and To Compare the Difference of Inflammasome Response of Inflammatory Macrophage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. To investigate the inflammasome response of inflammatory and resting macrophage derived from healthy human participants by stimulation using MAC or MAB bacilli. 2. To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB bacilli stimulation between MAC/MAB-LD patients and the… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage, To Compare the Difference of Inflammasome Response of Inflammatory Macrophage, To Study the Diagnostic Aid From Immunological Markers in Inflammasome Response
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Aug 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Age ≥ 20 years 2. MAC/MAB lung disease: Diagnosis is based on the guidelines made by American Thoracic Society (Table 1)[1]. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria. 3. MAC/MAB pulmonary colonizers: Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC/MAB are defined. 4. Healthy controls: patient without documented MAC/MAB lung disease and pulmonary colonization
Who may be able to join
- Age ≥ 20 years
- MAC/MAB lung disease: Diagnosis is based on the guidelines made by American Thoracic Society (Table 1)[1]. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria.
- MAC/MAB pulmonary colonizers: Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC/MAB are defined.
- Healthy controls: patient without documented MAC/MAB lung disease and pulmonary colonization
Who cannot join
- Patients who have acquired immunodeficiency syndrome
- Patients who have bleeding tendency which cannot tolerate venous puncture such as hemophilia, thrombocytopenia.
- refusal of recruitment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chin-CHung Shu, MD, 886-972653087
About this study
- To investigate the inflammasome response of inflammatory and resting macrophage derived from healthy human participants by stimulation using MAC or MAB bacilli.
- To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB bacilli stimulation between MAC/MAB-LD patients and the colonizers.
- To study the diagnostic aid from immunological markers in inflammasome response in inflammatory macrophage stimulated by MAC/MAB.
Read the detailed description
Lung disease (LD) due to nontuberculous mycobacteria (NTM) becomes an important clinical concern, because the incidence and prevalence of NTM-LD have increased over the last decade. Among the NTM-LD in Taiwan, Mycobacterium avium complex (MAC) and M. abscessus (MAB) are the most frequent pathogenic species. Because MAC and MAB exist in the environment ubiquitously, clinical relevance of MAC isolated in sputum is only around 35~42%, and that of MAB is around 33%. According to the guideline of the American Thoracic Society, the diagnosis of MAC-LD and MAB-LD is based on clinical, radiographic, and mycobacteriologic criteria. For microbiology criteria, two or more sets of positive sputum mycobacterial culture for the same NTM species within one year is required. Actually, mycobacteria culture is neither timely nor efficient, which needs weeks to wait the results, especially for the slowly growing NTM. Moreover, the nucleic acid amplification method cannot discriminate true NTM infection and solely colonization because airway NTM colonization is not uncommon. Therefore, diagnosis of true NTM-LD is a big challenge in clinical practice. However, to early diagnose and then start treatment of NTM-LD is important because NTM-LD may be rapid lethal in critical status or in patients without early proper treatment. Hence, more rapid and accurate diagnostic test should be developed.
The body inflammatory markers are probably indicators for differentiating true NTM-LD from pulmonary colonization and interferon-gamma (IFN-g) play a critical role in protective immunity to mycobacterial infections. However, serum IFN-g poorly correlated with diagnosis of NTM-LD and possibly due to the hosts with attenuated cellular immunity and the presence of IFN-gamma inhibitor. By contrast, macrophages are the first-line defense while mycobacterial bacilli enter through airway and may play an important role while MAC/MAB infection. Macrophages can be polarized to inflammatory type and promotes type 1 immunity. In addition, inflammatory macrophages can react through inflammasome to defense intracellular mycobacteria. However, the inflammasome responses in inflammatory macrophages are rarely investigated in MAC-LD and MAB-LD, either for the defense mechanism or its diagnostic aid for disease form colonization. The investigators therefore conduct an in-vitro inflammatory macrophage stimulation using MAC or MAB bacilli to observe the difference of inflammasome response between MAC/MAB patients, colonizers, and controls.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | patients without MAC/MAB lung disease and colonization | |
| MAC/MAB colonization group | patients with pulmonary MAC/MAB colonization | |
| MAC/MAB lung disease group | Patient with MAC/MAB lung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: one year
Secondary outcomes (1)
the amount of cytokine released by inflammatory macrophage
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Investigate the Inflammasome Response of Inflammatory and Resting MacrophageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005094
- Sponsor's protocol ID
- 201308008RINA
- Status last verified
- Jun 2014
- First submitted
- 26 Nov 2013
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammasome in Inflammatory Macrophage in Mycobacterium Avium Complex-lung Disease and Mycobacterium Abscessus-lung Disease
- ClinicalTrials.gov ID
- NCT02005094
- Acronym / sponsor ID
- 201308008RINA
- Conditions
- To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage, To Compare the Difference of Inflammasome Response of Inflammatory Macrophage, To Study the Diagnostic Aid From Immunological Markers in Inflammasome Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- 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.
- To investigate the inflammasome response of inflammatory and resting macrophage derived from healthy human participants by stimulation using MAC or MAB bacilli.
- To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB bacilli stimulation between MAC/MAB-LD patients and the colonizers.
- To study the diagnostic aid from immunological markers in inflammasome response in inflammatory macrophage stimulated by MAC/MAB.
Detailed description
Lung disease (LD) due to nontuberculous mycobacteria (NTM) becomes an important clinical concern, because the incidence and prevalence of NTM-LD have increased over the last decade. Among the NTM-LD in Taiwan, Mycobacterium avium complex (MAC) and M. abscessus (MAB) are the most frequent pathogenic species. Because MAC and MAB exist in the environment ubiquitously, clinical relevance of MAC isolated in sputum is only around 35~42%, and that of MAB is around 33%. According to the guideline of the American Thoracic Society, the diagnosis of MAC-LD and MAB-LD is based on clinical, radiographic, and mycobacteriologic criteria. For microbiology criteria, two or more sets of positive sputum mycobacterial culture for the same NTM species within one year is required. Actually, mycobacteria culture is neither timely nor efficient, which needs weeks to wait the results, especially for the slowly growing NTM. Moreover, the nucleic acid amplification method cannot discriminate true NTM infection and solely colonization because airway NTM colonization is not uncommon. Therefore, diagnosis of true NTM-LD is a big challenge in clinical practice. However, to early diagnose and then start treatment of NTM-LD is important because NTM-LD may be rapid lethal in critical status or in patients without early proper treatment. Hence, more rapid and accurate diagnostic test should be developed.
The body inflammatory markers are probably indicators for differentiating true NTM-LD from pulmonary colonization and interferon-gamma (IFN-g) play a critical role in protective immunity to mycobacterial infections. However, serum IFN-g poorly correlated with diagnosis of NTM-LD and possibly due to the hosts with attenuated cellular immunity and the presence of IFN-gamma inhibitor. By contrast, macrophages are the first-line defense while mycobacterial bacilli enter through airway and may play an important role while MAC/MAB infection. Macrophages can be polarized to inflammatory type and promotes type 1 immunity. In addition, inflammatory macrophages can react through inflammasome to defense intracellular mycobacteria. However, the inflammasome responses in inflammatory macrophages are rarely investigated in MAC-LD and MAB-LD, either for the defense mechanism or its diagnostic aid for disease form colonization. The investigators therefore conduct an in-vitro inflammatory macrophage stimulation using MAC or MAB bacilli to observe the difference of inflammasome response between MAC/MAB patients, colonizers, and controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | –patients without MAC/MAB lung disease and colonization |
| MAC/MAB colonization group | – | –patients with pulmonary MAC/MAB colonization |
| MAC/MAB lung disease group | – | –Patient with MAC/MAB lung disease |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age ≥ 20 years 2. MAC/MAB lung disease: Diagnosis is based on the guidelines made by American Thoracic Society (Table 1)[1]. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria. 3. MAC/MAB pulmonary colonizers: Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC/MAB are defined. 4. Healthy controls: patient without documented MAC/MAB lung disease and pulmonary colonization
Key inclusion criteria (4 listed)
- Age ≥ 20 years
- MAC/MAB lung disease: Diagnosis is based on the guidelines made by American Thoracic Society (Table 1)[1]. In brief, there should be pulmonary symptoms, comparable findings in chest image and appropriate exclusion other possible causes as well as meeting the microbiology criteria.
- MAC/MAB pulmonary colonizers: Those without fulfilling the diagnostic criteria but having at least one set of positive sputum for MAC/MAB are defined.
- Healthy controls: patient without documented MAC/MAB lung disease and pulmonary colonization
Key exclusion criteria (3 listed)
- Patients who have acquired immunodeficiency syndrome
- Patients who have bleeding tendency which cannot tolerate venous puncture such as hemophilia, thrombocytopenia.
- refusal of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival
Time frame: one year
1 secondary outcome
the amount of cytokine released by inflammatory macrophage
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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.
Chin-Chung Shu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage and To Compare the Difference of Inflammasome Response of Inflammatory Macrophage, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 30 Jun 2014. 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 Taiwan. 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 Chin-Chung Shu, MD (886-972653087, stree139@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: one year). 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 30 Jun 2014.