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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05354583
Enrollment
36
Registered
2022-04-29
Start date
2022-06-15
Completion date
2023-09-30
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGAppropriate 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

Sponsors

King Chulalongkorn Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Unfavorable Treatment OutcomeThe start of appropriate treatment to one year after thatThe occurring of any unfavorable events including 1. 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) 2. Radiological unfavorable event which is stable or worsen radiological features related to M. abscessus infection after 6 weeks of treatment 3. 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

MeasureTime frameDescription
Demographic dataAt the time that M. abscessus infection is diagnosed through study completion, about one yearAge, sex, nationality, religion, occupation, birth place, current residence
Proportion of Subspecies of Mycobacterium abscessusAt the time that M. abscessus infection is diagnosed through study completion, about one yearSubspecies from the first mycobacterial culture result including subsp. abscessus, massiliense, and boletii
Drug resistance rate of Mycobacterium abscessusAt the time that M. abscessus infection is diagnosed through study completion, about one yearRate of resistance to each class of antibiotics acquired from the first in vitro susceptibility test that is done as resisted, susceptible, or intermediate

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026