Efficacy of doxycycline as an add on therapy in drug sensitive cavitary pulmonary tuberculosis patients- A randomized placebo 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
- Matrix metalloproteinase 1
研究概览
简要总结
Following approval from PGRMC, State operational research committee and Institutional Ethics Committee, trial is registered in CTRI following which enrolment of the patient will begin based on the eligibility criteria after obtaining written informed consent. Patient will then be assessed for the baseline parameters like age, BMI, comorbidities, socioeconomic status, occupation, nutritional history, sputum microscopy/ culture, will be assessed and baseline blood parameters like low dose chest CT, CBC, RFT, LFT, RBS, MMP-1,3,8 will be measured and St George respiratory questionnaire will be administered. Patient will be randomly allocated to take capsule doxycycline 100mg or placebo twice daily for 4weeks. Adherence and adverse effects will be enquired over phone and adherence also ensured by pill count method. At the end of 4weeks blood sample will be collected for CBC, RFT, LFT, RBS, MMP-1,3,8. At the end of TB therapy (6months) patient will be repeated with low dose chest CT, St George respiratory questionnaire and spirometry will also be done. Sputum microscopy/ culture will be done at the end of intensive therapy and at the end of TB therapy. If patient develops any adverse events will be monitored and treated accordingly. Both per- protocol and intention to treat analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Females (who have completed their family or undergone sterilization)and males- who were newly diagnosed clinically and microbiologically confirmed drug sensitive pulmonary tuberculosis patients who have been receiving anti-tubercular therapy for ≤ 7days or about to start standard ATT with chest X-Ray demonstrating pulmonary cavity/cavities.
排除标准
- •Patients with extra pulmonary tuberculosis, previous history of pulmonary TB, HIV coinfections, severe preexisting lung diseases (such as fibrosis, COPD, lung cancer, bronchiectasis) and autoimmune diseases Patients with ALT/ AST >3 times upper limit of normal Patients with Creatinine > 2 times upper limit of normal Patient on antiepileptic therapy Known hypersensitivity to tetracyclines Patients who have taken tetracycline in the past 30 days preceding the dosing of study drug Patient who participated in other clinical trials in past 180 days.
结局指标
主要结局
Matrix metalloproteinase 1
时间窗: Baseline, 1month
次要结局
- Cumulative lung cavity volume, wall thickness, lobe involvement, CT severity score using Low dose Chest CT(Baseline, 6months)
- Matrix Metalloproteinases 3,8(Baseline, 1month)
- Pulmonary function test(6 months)
- Sputum microscopy/ culture(Baseline, end of intensive therapy, end of tuberculosis therapy)
- Quality of life using St George Respiratory Questionnaire(Baseline, 6months)
研究者
Maheshwari P
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry