Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
研究概览
简要总结
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.
详细描述
Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parasitologically confirmed, primarily ulcerative, Old World CL, in a patient who had either failed pentavalent antimony treatment, or who was ineligible for pentavalent antimony therapy.
- •Military health care beneficiary 18 years of age or greater, unless active military in which case, 17 years is the minimum age
- •Proven parasitological diagnosis by culture, PCR or microscopy in at least one skin lesion
- •Lesions primarily ulcerative (i.e., not verrucous or nodular)
- •Written informed consent to participate in protocol
- •Negative pregnancy test within 72 hours of starting protocol
- •Agrees to take precautions not to become pregnant or father a child for at least two months after completion of treatment with WR 279,396
- •Cutaneous leishmaniasis acquired in Southwest Central Asia/Middle East*
- •Inadequate response to treatment with pentavalent antimony or medical condition that precludes the use of pentavalent antimony
排除标准
- •Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient
- •any leishmanial lesion on mucosal surface
- •Presence of signs or symptoms of peripheral neuropathic myasthenia gravis, neuromuscular block
- •Routinely taking nephrotoxic or ototoxic medications
- •Disseminated disease defined as clinically significant subcutaneous nodules that are in the lymphatic drainage tract for the skin lesion with regional adenopathy > 1 cm
- •Abnormal Romberg test at baseline
- •Clinically significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:
- •Kidney: Creatinine > 2x the upper limit of normal
- •Liver: ASTor ALT >4x the upper limit fo normal
- •This includes "L. major," "L. tropica," and "L. infantum" with over 98% of cases in U.S. military in 2002-2004 being "L. major"
- •An inadequate response to treatment with pentavalent antimony includes patients who show no or little improvement during a 15-20 day treatment course, those that initially epithelialize but later show signs of breakdown/ ulceration or develop new lesions. In general, for those with initial treatment response, would recommend waiting for approximately two months after pentavalent antimony and if lesion is not epithelialized at that time, consideration for further therapy is advised.
研究组 & 干预措施
Paromomycin +Gentamicin topical cream
WR279,396 topically twice a day for 20 days
干预措施: Paromomycin +Gentamicin topical cream (Drug)
结局指标
主要结局
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
时间窗: 180 days
Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.
次要结局
- Number of Relapses(180 days)
- Safety and Tolerability (SAE's and AE's)(180 days)