NCT00495339已完成4 期
Multicenter Open Non-Comparative Clinical Study to Evaluate the Efficacy and Safety of Three Months TAVANIC Course (Levofloxacin) in Combine Treatment of Multi-Drug-Resistant Tuberculosis (MDR-TB)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with bacterioexcretion
研究概览
简要总结
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Drug-resistant pulmonary tuberculosis laboratory diagnosed
排除标准
- •Known hypersensitivity to levofloxacin, other quinolones
- •Patient with epilepsy and central nervous system diseases
- •Renal insufficiency with serum creatinine lower than 50 ml/min
- •Arterial hypertension, ischemic heart disease in acute phase
- •Gastro-intestinal diseases, liver diseases in acute phase
- •History of drug and alcohol abuse
- •Patient with history of tendon disorders related to fluoroquinolone administration
- •Pregnancy and breast-feeding women
- •Immune system disorders related to chemotherapy, AIDS, long term administration of corticosteroids
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Levofloxacin
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Number of patients with bacterioexcretion
时间窗: 1 month, 2 months, 3 months
Dynamics of Intoxication
时间窗: 1 month, 2 months, 3 months
Dynamics of chest radiograph
时间窗: 3 months
All clinical and laboratory adverse events
时间窗: from the signature of the Informed Concent Form (ICF) up to the end of the study
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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