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NCT Number: NCT05354583

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

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.

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Key information

Conditions

Mycobacterium Abscessus Infection Actinomycetales Infections Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Nontuberculous Mycobacterial Pulmonary Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appropriate treatment

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

Primary outcomes

  1. Proportion of Unfavorable Treatment Outcome

    Time frame: The start of appropriate treatment to one year after that

    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

Secondary outcomes

  1. Demographic data

    Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year

    Age, sex, nationality, religion, occupation, birth place, current residence

  2. Proportion of Subspecies of Mycobacterium abscessus

    Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year

    Subspecies from the first mycobacterial culture result including subsp. abscessus, massiliense, and boletii

  3. Drug resistance rate of Mycobacterium abscessus

    Time frame: At the time that M. abscessus infection is diagnosed through study completion, about one year

    Rate of resistance to each class of antibiotics acquired from the first in vitro susceptibility test that is done as resisted, susceptible, or intermediate

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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