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

Nontuberculous Mycobacterial Pulmonary Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05354583
• Other study ID #: 46/2565
• Status: Completed
• Start date: June 15, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Immunologic Deficiency Syndromes
• Infections
• Lung Diseases
• Mycobacterium Abscessus Infection
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Nontuberculous Mycobacterial Pulmonary Infection

Intervention

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

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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