Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection

Intervention / Treatment
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* Drug: Appropriate treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acquired Interferon-gamma Autoantibody Syndrome<br>Patients infected with M. abscessus at any site, who have acquired interferon-gamma autoantibody syndrome defined as one of the following features: The M. abscessus infection site is lymph node. The M. abscessus infection is disseminated (more than 1 organ of infection or blood culture positive for M. abscessus). The M. abscessus infection is accompanied by one of reactive skin diseases which are Sweet's syndrome, pustular psoriasis, erythema nodosum. 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. | Drug: Appropriate treatment<br>* 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<br>|
| Chronic Lung Disease<br>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: Symptoms and signs are correlated with the pulmonary M. abscessus infection. 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 Mycobacterial culture from respiratory tract specimen is positive for M. abscessus | Drug: Appropriate treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The start of appropriate treatment to one year after that | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Age, sex, nationality, religion, occupation, birth place, current residence | 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 | 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 | At the time that M. abscessus infection is diagnosed through study completion, about one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency with Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection