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

NCT05354583 | Completed

• 1 other identifier: 46/2565
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Unfavorable Treatment Outcome

  The 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

  The start of appropriate treatment to one year after that

Secondary Outcomes (3)

• Demographic data

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

• Proportion of Subspecies of Mycobacterium abscessus

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

• Drug resistance rate of Mycobacterium abscessus

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

Study Arms (2)

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: 1. The M. abscessus infection site is lymph node. 2. The M. abscessus infection is disseminated (more than 1 organ of infection or blood culture positive for M. abscessus). 3. The M. abscessus infection is accompanied by one of reactive skin diseases which are Sweet's syndrome, pustular psoriasis, erythema nodosum. 4. 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

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: 1. Symptoms and signs are correlated with the pulmonary M. abscessus infection. 2. One of the radiological evidences: 2.1) nodular infiltration or cavitary lesion on plain chest radiography 2.2) bronchiectasis and multiple small nodules on chest computerized tomography 3. Mycobacterial culture from respiratory tract specimen is positive for M. abscessus

Drug: Appropriate treatment

Interventions

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

Acquired Interferon-gamma Autoantibody Syndrome; Chronic Lung Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Warat Usawakidwiree, M.D.

  Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

• Chusana Suankratay, M.D., Ph.D.

  Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine resident

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 29, 2022
• Study Start: June 15, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

TH (1)