NCT00216346已完成3 期
A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
PATH7 个研究点 分布在 1 个国家目标入组 667 人开始时间: 2003年6月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 667
- 试验地点
- 7
- 主要终点
- (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
研究概览
简要总结
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
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
- 5 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5-55 years (inclusive) of either gender.
- •Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
- •Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
- •Biochemical and haematological test values as follows:
- •Haemoglobin > 5.0g/100mL
- •White blood cell count > 1 x109/L
- •Platelet count > 50 x 109/L
- •AST, ALT and alkaline phosphatase < 3 times upper normal limit
- •Prothrombin time < 5 seconds above control
- •Serum creatinine levels within normal limits
- •Serum potassium levels within normal limits
- •HIV negative
排除标准
- •A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- •Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- •An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
- •Proteinuria (> 2+).
- •A history of allergy or hypersensitivity to aminoglycosides.
- •A history of major surgery within the last two weeks.
- •Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.]
- •Previous treatment for VL within two weeks of enrolment into the study.
- •Prior treatment failures with paromomycin or amphotericin B.
结局指标
主要结局
(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
次要结局
- - Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
- - Comparison of initial cure rates for the two regimens
- - Comparison of clinical improvement rates for the two regimens
研究者
研究点 (7)
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