A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
研究概览
简要总结
This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
详细描述
A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Department of Defense (DOD) Healthcare beneficiary
- •Parasitologic diagnosis of cutaneous Leishmania infection
- •(Inclusion criteria for randomization includes that must be Leishmania major species)
- •Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed
- •(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)
- •Able to provide informed consent
- •All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate
排除标准
- •Unable to provide informed consent
- •Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone [HCG] within 48 hours of the start of infusion period)
- •History of hypersensitivity to pentavalent antimonials
- •Serious medical illness:
- •QTc interval >/= 0.5 sec
- •severe cardiac disease
- •history of current pancreatitis
- •liver failure or active hepatitis with transaminases >3X normal
- •renal failure or creatinine >2.5
- •thrombocytopenia (platelets <75,000)
- •white blood cell count <2000
- •hematocrit <25
- •absence of palpable extremity pulses in the limb requiring treatment
- •History of serious allergic reaction to local anesthetics
- •Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)
- •Presence of pacemaker and/or other implanted metallic devices
- •Breast feeding
- •Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment
- •Women unwilling to avoid pregnancy for at least two months after receiving the treatment
- •More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy
研究组 & 干预措施
ThermoMed device
ThermoMed device, single heat treatment at 50 degrees Celsius
干预措施: ThermoMed (Device)
Sodium stibogluconate intravenous
20 mg/kg/day Sodium stibogluconate intravenous
干预措施: Sodium stibogluconate (Pentostam) (Drug)
结局指标
主要结局
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
时间窗: Assessment of cure is made at 2 months after treatment
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
次要结局
- Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure(12 months)
- Number of Participants With Solicited Adverse Events(Days 3, 7 and 10)
- Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments(day 1 and day 10)
- Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments(day 1 and day 10)
- Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial(at baseline before treatment)