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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of Unfavorable Treatment Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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:
- The M. abscessus infection site is lymph node.
- The M. abscessus infection is disseminated (more than 1 organ of infection or blood culture positive for M. abscessus).
- The M. abscessus infection is accompanied by one of reactive skin diseases which are Sweet's syndrome, pustular psoriasis, erythema nodosum.
- 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.
干预措施: Appropriate treatment (Drug)
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:
- Symptoms and signs are correlated with the pulmonary M. abscessus infection.
- 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
干预措施: Appropriate treatment (Drug)
结局指标
主要结局
Proportion of Unfavorable Treatment Outcome
时间窗: The start of appropriate treatment to one year after that
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
次要结局
- 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)
研究者
Warat Usawakidwiree
Internal medicine resident
King Chulalongkorn Memorial Hospital