The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in TB-score compared to baseline (Wejse et al 2007)
研究概览
简要总结
The purpose of this study is to investigate whether treatment against intestinal helminths in patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.
详细描述
Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem. Because of increasing multi drug resistance and the long treatment period of at least six months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is endemic, chronic worm infection is also highly prevalent. Recent data support that helminth infection might limit the host response against TB by inhibition of the TH1-response that is crucial in controlling the disease. In this study we want to test the hypothesis that Albendazole treatment of patients coinfected with helminths and TB could improve clinical outcome in addition to chemotherapy against TB. Additionally we will investigate the immunological interactions between TB and chronic helminths infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and written consent to take part in the study
- •Newly diagnosed pulmonary TB patients according to the WHO definitions of active tuberculosis who have a positive stool sample for helminths other than Schistosoma spp.
排除标准
- •Pregnancy
- •Corticosteroid or antibiotic treatment
- •Symptomatic (diarrhoea) infection caused by worm infection
- •Chronic diseases or acute infectious diseases other than TB or HIV
- •Stool sample positive for Schistosoma spp
研究组 & 干预措施
Albendazole
Albendazole 400mg per os once daily for three consecutive days
干预措施: Albendazole (Drug)
Placebo
Placebo 400mg per os for three consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in TB-score compared to baseline (Wejse et al 2007)
时间窗: 2 months
次要结局
- Final outcome according to WHO(6 months)
- Chest X-ray improvement(3 months)
- Sputum smear conversion(3 months)
- Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)(3 months)
- Immunological response (IgE, Eosinophils, CD4-count)(3 months)
研究者
Thomas Schon
MD PhD
Linkoeping University