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

NCT ID: NCT05354583

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-09-30

Brief 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 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Appropriate treatment

Intervention Type: DRUG

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

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

Appropriate treatment

Intervention Type: DRUG

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

Interventions

Appropriate treatment

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Warat Usawakidwiree

Internal medicine resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warat Usawakidwiree, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Chusana Suankratay, M.D., Ph.D.

Role: STUDY_DIRECTOR

Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Locations

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Countries

Thailand

Other Identifiers

46/2565

Identifier Type: -

Identifier Source: org_study_id