Clinical trial NCT05354583: Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit King Chulalongkorn Memorial Hospital (a tertiary care hospital in Thailand) during the study period

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.

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

Primary outcomes:
measure: Proportion of Unfavorable Treatment Outcome
timeFrame: The start of appropriate treatment to one year after that
Secondary outcomes:
measure: Demographic data
timeFrame: At the time that M. abscessus infection is diagnosed through study completion, about one year
measure: Proportion of Subspecies of Mycobacterium abscessus
timeFrame: At the time that M. abscessus infection is diagnosed through study completion, about one year
measure: Drug resistance rate of Mycobacterium abscessus
timeFrame: At the time that M. abscessus infection is diagnosed through study completion, about one year
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
name: Warat Usawakidwiree, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
name: Chusana Suankratay, M.D., Ph.D.
role: STUDY_DIRECTOR
References: