N-acetyl cysteine therapy in patients with Pulmonary tuberculosis: A Pilot Open- Label Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The change in pre-bronchodilator FVC and FEV1 between the two groups at 2 months from baseline
研究概览
简要总结
Introduction: Current treatment strategies in Pulmonary TB are effective in curing the disease but have several problems, including residual lung damage as evidenced by spirometry and radiological changes. There is also a significant risk of relapse of disease due to persisters.
Hypothesis: We hypothesize that using NAC with ATT causes reduction in lung destruction, preservation of lung function, and early sputum sterilization in pulmonary tuberculosis.
Objectives: To assess the change in FVC and FEV1 at two months of therapy. Other objectives include microbiological clearance, radiological improvement, change in biomarkers, and quality of life.
Methods: Pilot open-label randomized controlled trial of addition of NAC to standard ATT during six months therapy for pulmonary tuberculosis. All patients will be followed up with serial spirometry, chest radiograph, six-minute walk test, and St. George’s respiratory questionnaire to assess the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years or more.
- •Willing to give written informed consent.
- •Body weight ≥ 30 kg.
- •Pulmonary TB diagnosed with One sputum OR Bronchoalveolar lavage GeneXpert test positive.
- •No detection of Rifampicin resistance by GeneXpert/ LPA/ MGIT C/S.
- •A chest radiograph abnormality consistent with tuberculosis.
- •No prior history of ATT.
- •Willing to undergo HIV serology testing.
- •Agrees to use effective barrier contraception during the period of the study.
- •Residing around the study site (AIIMS, Delhi).
- •Express willingness to attend the treatment center for supervised treatment.
排除标准
- •Clinically significant evidence of extrapulmonary TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
- •Poor general condition as assessed by the study investigator.
- •Renal dysfunction including (but not limited to) serum creatinine levels above the upper limit of the laboratory reference range (Serum creatinine >1.2 mg/dL or blood urea >43 mg/dL)
- •Has clinical jaundice or hepatic impairment characterized by serum bilirubin level above 1.2 times upper limit of the laboratory reference range, or by alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels >3 times the upper limit of the laboratory reference range
- •Diabetes mellitus or Psychiatric illness
- •Serology positive for HBSAg Or Hepatitis C virus antibody Or HIV
- •Pregnant or lactating females
- •Has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe
- •Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- •Has a known allergy to any of the drugs proposed to be used in the trial regimen
- •Has evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.
结局指标
主要结局
The change in pre-bronchodilator FVC and FEV1 between the two groups at 2 months from baseline
时间窗: 2 months
次要结局
- The proportion of patients having radiological improvement/stabilisation at two months and six months(2 months and 6 months)
- The proportion of patients having sputum/ BAL culture negativity at two weeks(Two weeks)
- The change in pre-bronchodilator FVC and FEV1 between the two groups at 6 months(6 months)
- To compare the change in biomarkers of oxidative stress & inflammation at 2 month between NAC containing arm and the control arm(2 months)
- The proportion of patients having “unfavorable outcome†at 6 months (defined as composite of radiologically active disease, sputum culture positive, death due to tuberculosis and NAC discontinuation)(6 months)
- The proportion of patients having IGRA positivity at the end of 6 months(6 months)
- The number of adverse events between the NAC containing arm and control arm during 6 months of therapy(6 months)
研究者
Saurabh Mittal
All India Institute of Medical Sciences, New Delhi