"A Prospective, Randomized, Comparative Clinical Trial of the Efficacy and Safety of Levofloxacin Versus Isoniazid in the Treatment of Latent Tuberculosis Infection in Liver Transplant Patients".
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 18
- 主要终点
- Difference in incidence of tuberculosis disease
研究概览
简要总结
A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation.
Patients over 18 years of age on the waiting list for liver transplantation.
Sample size: n=870 patients.
HYPOTHESIS
Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.
详细描述
Primary Objective
- To demonstrate that the incidence of tuberculosis in patients with latent tuberculosis infection and treated with levofloxacin is not higher than that observed in patients treated with isoniazid.
Secondary Objective 2. To demonstrate that the efficacy of levofloxacin is not limited by adverse effects, paying particular attention to hepatotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Liver transplantation candidates with age ≥ 18 years, no clinical or radiological evidence of active tuberculosis and negative pregnancy test (if applicable)who must meet one or more of the following criteria:
- •PPD skin test (initial or after a "booster effect") >5 mm. Alternatively, the determination may be made by the interferon gamma (IFN-g) production in PPD-stimulated lymphocytes using the Quantiferon-TB or ELISPOT assays.
- •Past history of tuberculosis not properly treated.
- •Past history of contact with a patient with active TB.
- •Chest x-ray consistent with past untreated TB (apical fibronodular lesions, calcified solitary nodule, calcified lymph nodes or pleural thickening).
- •The patient must give their written informed consent.
排除标准
- •Lack of consent to participate in the study.
- •Intolerance or allergy to levofloxacin or to isoniazid.
- •Documented contact with tuberculosis resistant to levofloxacin or to isoniazid.
- •Treatment in the previous month with drugs with potential activity against Mycobacterium tuberculosis, (especially quinolones).
研究组 & 干预措施
levofloxacin
Levofloxacin 500 mg daily for 9 months starting on the waiting list for liver transplant
干预措施: Levofloxacin (Drug)
Isoniazid
Isoniazid 300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months
干预措施: Isoniazid (Drug)
结局指标
主要结局
Difference in incidence of tuberculosis disease
时间窗: 18 months of follow-up
A patient will be considered as having tuberculosis when Mycobacterium tuberculosis is isolated by culture or M. Tuberculosis DNA is isolated from a representative clinical sample, organ fluid or tissue by polymerase chain reaction. Also cases of histopathologically confirmed tuberculosis (caseating granulomas with/without demonstration of acid-alcohol resistant bacillus \[BAAR\]) and clinically compatible presentation will be accepted. Tuberculosis will be classified as pulmonary (pulmonary parenchymal involvement), extrapulmonary (involvement of different organs to the lung) or disseminated (involvement of at least two non-contiguous organs). Cases where tuberculosis is diagnosed on the basis of clinical and/or radiology suspicion and for whom the corresponding physician has prescribed a specific treatment will not be accepted.
次要结局
- Transplant rejection(18 months)
- Toxicity(During all the 18 months of follow-up)
- Retransplantation(18 months)
- Graft dysfunction(18 months)
- Mortality(18 months)