Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Total initial cicatrization
研究概览
简要总结
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).
详细描述
The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups.
The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CL clinical diagnosis (presence of an ulcer)
- •CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border
- •Presence of one to a maximum of three ulcers
- •Ulcer size between 1 and 5 mm
- •Ulcer evolution of 1 to 6 months
排除标准
- •Previous CL treatment
- •Renal or hepatic disease
- •HIV co-infection.
研究组 & 干预措施
Group Anfo12mg/kg
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg
干预措施: Liposomal amphotericin B (AmBisome®) (Drug)
Group Anfo18mg/kg
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg
干预措施: Liposomal amphotericin B (AmBisome®) (Drug)
Group Anfo24mg/kg
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg
干预措施: Liposomal amphotericin B (AmBisome®) (Drug)
结局指标
主要结局
Total initial cicatrization
时间窗: 30 to 90 days after the first day of treatment
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
次要结局
- Total final cicatrization(30 to 180 days after the first day of treatment)
- Time to cure(30 to 180 days after the first day of treatment)
研究者
Paulo Roberto Lima Machado
Head of Immunology Service
Hospital Universitário Professor Edgard Santos