Mycobacterium Abscessus InfectionNCT05354583
Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome
An observational study of Mycobacterium Abscessus Infection and Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied. Investigators will perform a retrospective and prospective cohort study to determine the treatment outcome of Mycobacterium abscessus infection in patients with acquired… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- What is being tested?
- Appropriate treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jun 2022to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit King Chulalongkorn Memorial Hospital (a tertiary care hospital in Thailand) during the study period
Who may be able to join
- Aged 18 years or over
- Diagnosed with Mycobacterium abscessus pulmonary disease in chronic lung disease or Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome
- Receive appropriate treatment
Who cannot join
- Follow up time less than one year after the start of appropriate treatment
- Very incomplete medical record that the subject's history cannot be reviewed
- Appropriate treatment duration less than one year at the study completion
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
About this study
Official title: Comparison Study of Unfavorable Treatment Outcome Between Mycobacterium Abscessus Infection in Patients With Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome Within 1 Year of Appropriate Treatment
The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied. Investigators will perform a retrospective and prospective cohort study to determine the treatment outcome of Mycobacterium abscessus infection in patients with acquired interferon-gamma autoantibody syndrome compared with the infection in patients with chronic lung disease which is known to be the most common group of infection and have high rates of treatment failure. Investigators hypothesized that Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has better outcome than infection in chronic lung disease.
Read the detailed description
The single center, retrospective and prospective cohort study including the patients, aged 18 years and over, with acquired interferon-gamma autoantibody syndrome or chronic lung disease diagnosed with M. abscessus infection in the tertiary hospital of Thailand from January 2014 to June 2023 will be perform. The enrolled M. abscessus infected patients will be divided into two groups which are acquired interferon-gamma autoantibody syndrome group and chronic lung disease group. The subjects' medical record will be reviewed for demographic data, underlying diseases, clinical signs and symptoms, laboratory and radiological investigation results, diagnosis, treatment that the patients received, clinical events during the treatment. The treatment outcome will be determined as unfavorable or favorable by present or absent of unfavorable events, settled by the investigators, within 1 years after the treatment. The treatment outcome and other secondary outcomes between the two groups will then be compared and analysed with chi-squared test for categorical variables and two-sample t-test for continuous variables.
- Conditions
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- Being tested
- Appropriate treatment
- Keywords
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency with Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appropriate treatmentDrug
Treatment with at least 3 antibiotics, which the pathogen is susceptible to based on in vitro drug susceptibility test, in the initial phase of the treatment
| Study group | Role | What they receive |
|---|---|---|
| Acquired Interferon-gamma Autoantibody Syndrome | Patients infected with M. abscessus at any site, who have acquired interferon-gamma autoantibody syndrome defined as one of the following features:
1. The M. abscessus infection site is lymph node.
2. The M. abscessus infection is disseminated (more than 1 organ of infection or blood culture positive for M. abscessus).
3. The M. abscessus infection is accompanied by one of reactive skin diseases which are Sweet's syndrome, pustular psoriasis, erythema nodosum.
4. History of opportunistic infection such as salmonellosis, penicillosis, histoplasmosis, cryptococcosis, melioidosis
The patients must not be infected with HIV, in-hospital M. abscessus infection, diagnosed with cancer, or receiving immunosuppressants. Receives: Drug: Appropriate treatment | |
| Chronic Lung Disease | Patients with one of chronic lung diseases which are COPD, chronic bronchiectasis, history of pulmonary tuberculosis and diagnosed with Pulmonary M. abscessus infection.
Pulmonary M. abscessus infection diagnosis must be met all of the following criteria:
1. Symptoms and signs are correlated with the pulmonary M. abscessus infection.
2. One of the radiological evidences:
2.1) nodular infiltration or cavitary lesion on plain chest radiography
2.2) bronchiectasis and multiple small nodules on chest computerized tomography
3. Mycobacterial culture from respiratory tract specimen is positive for M. abscessus Receives: Drug: Appropriate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Unfavorable Treatment Outcome
The occurring of any unfavorable events including
- Clinical unfavorable events which are 1.1) death relating to M. abscessus infection 1.2) ongoing or worsening of symptoms or signs of infection after 6 weeks of treatment 1.3) addition new class or changing class of antibiotics during treatment (not included changing antibiotics according to in vitro susceptibility test)
- Radiological unfavorable event which is stable or worsen radiological features related to M. abscessus infection after 6 weeks of treatment
- Microbiological unfavorable events which are 3.1) Acid fast bacilli positive from clinical specimen after 6 weeks of treatment 3.2) Mycobacterial culture positive for M. abscessus after 6 weeks of treatment
Measured: The start of appropriate treatment to one year after that
Secondary outcomes (3)
Demographic data
Age, sex, nationality, religion, occupation, birth place, current residence
Measured: At the time that M. abscessus infection is diagnosed through study completion, about one year
Proportion of Subspecies of Mycobacterium abscessus
Subspecies from the first mycobacterial culture result including subsp. abscessus, massiliense, and boletii
Measured: At the time that M. abscessus infection is diagnosed through study completion, about one year
Drug resistance rate of Mycobacterium abscessus
Rate of resistance to each class of antibiotics acquired from the first in vitro susceptibility test that is done as resisted, susceptible, or intermediate
Measured: At the time that M. abscessus infection is diagnosed through study completion, about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start15 Jun 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus InfectionStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warat Usawakidwiree, King Chulalongkorn Memorial Hospital
- Investigators
- Warat Usawakidwiree, M.D., Principal investigator, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, ThailandChusana Suankratay, M.D., Ph.D., Study director, Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354583
- Sponsor's protocol ID
- 46/2565
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Unfavorable Treatment Outcome Between Mycobacterium Abscessus Infection in Patients With Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome Within 1 Year of Appropriate Treatment
- ClinicalTrials.gov ID
- NCT05354583
- Acronym / sponsor ID
- 46/2565
- Conditions
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- Keywords
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency with Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Apr 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.
The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied. Investigators will perform a retrospective and prospective cohort study to determine the treatment outcome of Mycobacterium abscessus infection in patients with acquired interferon-gamma autoantibody syndrome compared with the infection in patients with chronic lung disease which is known to be the most common group of infection and have high rates of treatment failure. Investigators hypothesized that Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has better outcome than infection in chronic lung disease.
Detailed description
The single center, retrospective and prospective cohort study including the patients, aged 18 years and over, with acquired interferon-gamma autoantibody syndrome or chronic lung disease diagnosed with M. abscessus infection in the tertiary hospital of Thailand from January 2014 to June 2023 will be perform. The enrolled M. abscessus infected patients will be divided into two groups which are acquired interferon-gamma autoantibody syndrome group and chronic lung disease group. The subjects' medical record will be reviewed for demographic data, underlying diseases, clinical signs and symptoms, laboratory and radiological investigation results, diagnosis, treatment that the patients received, clinical events during the treatment. The treatment outcome will be determined as unfavorable or favorable by present or absent of unfavorable events, settled by the investigators, within 1 years after the treatment. The treatment outcome and other secondary outcomes between the two groups will then be compared and analysed with chi-squared test for categorical variables and two-sample t-test for continuous variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acquired Interferon-gamma Autoantibody Syndrome | – | Drug: Appropriate treatmentPatients infected with M. abscessus at any site, who have acquired interferon-gamma autoantibody syndrome defined as one of the following features: 1. The M. abscessus infection site is lymph node. 2. The M. abscessus infection is disseminated (more than 1 organ of infection or blood culture positive for M. abscessus). 3. The M. abscessus infection is accompanied by one of reactive skin diseases which are Sweet's syndrome, pustular psoriasis, erythema nodosum. 4. History of opportunistic infection such as salmonellosis, penicillosis, histoplasmosis, cryptococcosis, melioidosis The patients must not be infected with HIV, in-hospital M. abscessus infection, diagnosed with cancer, or receiving immunosuppressants. |
| Chronic Lung Disease | – | Drug: Appropriate treatmentPatients with one of chronic lung diseases which are COPD, chronic bronchiectasis, history of pulmonary tuberculosis and diagnosed with Pulmonary M. abscessus infection. Pulmonary M. abscessus infection diagnosis must be met all of the following criteria: 1. Symptoms and signs are correlated with the pulmonary M. abscessus infection. 2. One of the radiological evidences: 2.1) nodular infiltration or cavitary lesion on plain chest radiography 2.2) bronchiectasis and multiple small nodules on chest computerized tomography 3. Mycobacterial culture from respiratory tract specimen is positive for M. abscessus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit King Chulalongkorn Memorial Hospital (a tertiary care hospital in Thailand) during the study period
Key inclusion criteria (3 listed)
- Aged 18 years or over
- Diagnosed with Mycobacterium abscessus pulmonary disease in chronic lung disease or Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome
- Receive appropriate treatment
Key exclusion criteria (3 listed)
- Follow up time less than one year after the start of appropriate treatment
- Very incomplete medical record that the subject's history cannot be reviewed
- Appropriate treatment duration less than one year at the study completion
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 |
|---|---|---|
| Appropriate treatmentTreatment with at least 3 antibiotics, which the pathogen is susceptible to based on in vitro drug susceptibility test, in the initial phase of the treatment | Drug | Acquired Interferon-gamma Autoantibody Syndrome, Chronic Lung Disease |
Primary outcome
Proportion of Unfavorable Treatment Outcome
Time frame: The start of appropriate treatment to one year after that
The occurring of any unfavorable events including 1. Clinical unfavorable events which are 1.1) death relating to M. abscessus infection 1.2) ongoing or worsening of symptoms or signs of infection after 6 weeks of treatment 1.3) addition new class or changing class of antibiotics during treatment (not included changing antibiotics according to in vitro susceptibility test) 2. Radiological unfavorable event which is stable or worsen radiological features related to M. abscessus infection after 6 weeks of treatment 3. Microbiological unfavorable events which are 3.1) Acid fast bacilli positive from clinical specimen after 6 weeks of treatment 3.2) Mycobacterial culture positive for M. abscessus after 6 weeks of treatment
3 secondary outcomes
Demographic data
Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year
Proportion of Subspecies of Mycobacterium abscessus
Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year
Drug resistance rate of Mycobacterium abscessus
Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
Warat Usawakidwiree, M.D. principal investigator
Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Chusana Suankratay, M.D., Ph.D. study director
Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
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 Mycobacterium Abscessus Infection and Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 3 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: finished, as of the sponsor's last update on 10 Oct 2023. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Unfavorable Treatment Outcome (time frame: The start of appropriate treatment to one year after that). 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 Oct 2023.