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

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.

Study Overview

• Status: Completed
• Conditions: Mycobacterium Abscessus Infection; Nontuberculous Mycobacterial Pulmonary Infection; Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies
• Intervention / Treatment: Drug: Appropriate treatment

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who visit King Chulalongkorn Memorial Hospital (a tertiary care hospital in Thailand) during the study period

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: 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; 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: 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 radiography2.2) bronchiectasis and multiple small nodules on chest computerized tomography; Mycobacterial culture from respiratory tract specimen is positive for M. abscessus	Drug: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Warat Usawakidwiree, M.D., Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Study Director: Chusana Suankratay, M.D., Ph.D., Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mycobacterium Abscessus Infection; Adult-Onset Immunodeficiency with Acquired Anti-Interferon-Gamma Autoantibodies; Nontuberculous Mycobacterial Pulmonary Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Lung Diseases; Infections; Communicable Diseases; Mycobacterium Infections; Immunologic Deficiency Syndromes; Mycobacterium Infections, Nontuberculous
• Other Study ID Numbers: 46/2565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No