Safety and efficacy of a combination of Paromomycin and Miltefosine for two versus three courses in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL) - an exploratory pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.
研究概览
简要总结
Post Kala-Azar Dermal Leishmaniasis (PKDL) is considered as a reservoir of visceral leishmaniasis (VL). It plays an important role in disease transmission. No satisfactory treatment regimen is available at present which is hundred percent safe and effective. Moreover, the parasite also shows a gradual increase in tolerance and resistance. This study evaluates the efficacy and safety of a novel combination, i.e. paromomycin plus miltefosine in the treatment of PKDL, which has not been tried previously. This is a pilot exploratory study. Thirty patients were enrolled in two groups. Group A (n=15) received two courses of paromomycin 11mg/kg/day IM plus miltefosine 2.5 mg/kg/day orally (10 days) at fifteen-day interval, whereas group B (n=15) received three courses of paromomycin plus miltefosine combination. The efficacy of these therapies were ascertained by the final parasitological cure at one year follow up.Lesion of the group A patients did not disappear completely at the end of therapy so all the patients were shifted to receive three courses of the same combination. All the thirty patients completed the study. Initial and Final parasitological cure was found to be 100% and 83.33% respectively. A total of 63 AEs were reported in 24 patients. All the AEs were CTC grade one. Pain at the site of injection (28.6%) was most commonly occurring AE and increase in hepatic enzymes level, eosinophilia, vomiting, gastritis etc. were among others.Efficacy of this novel combination therapy appears to be optimal with excellent safety and tolerability profile. Further studies with a higher number of samples are recommended.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Male or female patients aged 5-65years • Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies) • Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis.
排除标准
- •â€¢ Any patients having any ear deformity, hearing loss and ASOM/CSOM.
- •â€¢ Pregnant and lactating females.
- •â€¢ Females not willing for contraception.
- •â€¢ Patients not willing to participate.
- •â€¢ Thrombocyte count <100 x 109/l • Leukocyte count <2.5 x 109/l • Hemoglobin < 8.0 g/100 ml • ASAT, ALAT, AP >3 times upper limit of normal range • Bilirubin >2 times upper limit of normal range • HbsAg, HCV and HIV positive • Serum creatinine or BUN >1.5 times upper limit of normal range • Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine.
结局指标
主要结局
Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.
时间窗: June 2013 to January 2016 including one year follow-up. Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.
次要结局
- Five patients out of thirty treated with Paromomycin and Miltefosine had relapse of the skin lesions within one year. However there was very slide change in the biochemical and haematological parameters.(June 2013 to January 2016 including one year follow-up post treatment. Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.)