An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Final cure rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).
详细描述
Safe, effective and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest populations are urgently needed in Bangladesh in areas where the disease is endemic. Paromomycin IM Injection (PMIM) was approved for the treatment of VL in August 2006 by the Drugs Controller General of India (DCGI), and it offers an attractive alternative to treatments that are currently available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signs and symptoms of VL including:
- •History of intermittent fever for at least two weeks
- •History of weight loss and/or decrease in appetite
- •Enlarged spleen
- •VL serologically confirmed using the rK39 test:
- •Willingness / ability to understand and provide informed consent prior to participation in this study:
- •Age ≥ five years and ≤ 55 years, and weighing at least five kg
- •Adequately hydrated as assessed by clinical criteria and able to maintain adequate hydration on an outpatient basis through oral intake of fluids
- •Clinically stable and appropriate for treatment with PMIM as an outpatient, if possible (subjects may be hospitalized to receive 21-day dosing at the discretion of the investigator)
- •Living in the VL-endemic areas in Bangladesh
排除标准
- •Active tuberculosis or taking anti-tuberculosis medications
- •Previous treatment with Paromomycin IM Injection (PMIM)
- •Clinically significant severe anemia as determined by the investigator
- •Clinically significant renal or hepatic dysfunction as determined by the investigator, or history of clinically significant renal or hepatic dysfunction
- •History of Hepatitis B or C; or known HIV positive
- •History of hearing loss
- •Other serious illness or medical condition that, in the opinion of the doctor, would interfere with the patient's ability to receive PMIM treatment or comply with the study procedures, or that could obscure toxicity of or response to PMIM
- •Major surgery within 30 days prior to first dose of PMIM
- •History of hypersensitivity to aminoglycosides or to any of the components of PMIM, including sulfite
- •Any history of VL or treatment of VL at any time
- •Patients who have received any investigational (unlicensed) drug within the last six months
- •Concomitant use of other aminoglycosides (e.g., gentamicin, tobramycin, amikacin), nephrotoxic and ototoxic drugs, or immunosuppressive drugs
- •Proteinuria (results > 1+ ) on urine dipstick analysis at screening visit and/or
- •Serum creatinine above the upper limit of normal (ie, serum creatinine >1.1 mg/dl in males and >0.9 mg/dl in females
- •Pregnant or lactating women
结局指标
主要结局
Final cure rate
时间窗: 6 months after end of treatment (Day 202/203, -15 to +30 days)
Criteria evaluated (binary fashion): 1. Patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N) 2. Patient reported resolution of fever and NO fever within the last 5 days? (Y/N) 3. Spleen size decreased from screening value? (Y/N) 4. Is the clinical impression of the treating physician that of an adequate clinical response? (Y/N) The patient is deemed to have achieved final cure if answers to a, b, c, AND d are all "Yes" OR if one answer (a, b, or c) is "No" but all others and "d" are "Yes". In addition, the clinician will inquire about pregnancy status for female patients.
次要结局
- Initial clinical response rate(End of treatment (21/22 days after treatment begins))
- Patient compliance with PMIM treatment(22 days)
- Safety of PMIM in the study population based on clinical assessment by the study physician at the Upazilla Health Centre.(6 months after end of treatment)
- To introduce PMIM in government health facilities in rural Bangladesh.(October 2011)