Cohort observational study to estimate the prevalence of Post Kala-Azar Dermal Leishmaniasis (PKDL) in Visceral Leishmaniasis (VL) patients treated with three regimens in Bihar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,761
- 试验地点
- 1
- 主要终点
- To determine the prevalence rate of Post Kala Azar Dermal Leishmaniasis (PKDL) during or more than 24 months post treatment in Kala Azar treated cases with any of the three treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 days
研究概览
简要总结
This is cohort observational study conducted in two districts of Bihar i.e. Saran and Vaishali district and tertiary referral centre RMRI, Patna. Kala Azar patients who have been previously treated with any one of new treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 days will be included in the study after fulfiling eligibility criteria.
All Kala Azar cases (n=1761) that have been treated during Aug 2012 to Oct 2014 in these 02 districts and RMRI in pilot implementation study with one of new treatment regimens will be considered as population of this study. The list of Kala Azar patients treated with new regimens would be obtained from district hospital and PHCs register.
Primary Objective: To determine the prevalence rate of Post Kala Azar Dermal Leishmaniasis (PKDL) during or more than 24 months post treatment in Kala Azar treated cases with any of the three treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 days
Secondary Objective:
a) To determine the average time of occurrence of PKDL after each treatment
b) To compare occurrence of PKDL in different treatment arms
Study Endpoints
Primary Endpoint: overall prevalence of PKDL in the cohort of patients treated with the three treatment regimens ie Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 days
Secondary Endpoints:
a) Average and 95% CI of the time to PKDL symptoms onset and time to PKDL diagnosis for the cohort of Kala azar patients treated with the 3 treatment regimens
b) Prevalence of probable and confirmed cases of PKDL for each treatment regimen by patient-months of follow-up period will be compared among the 3 treatment modalities
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All cases that have been previously diagnosed with sign and symptoms of Kala Azar and were rK 39 test or parasitology positive (by the time of the Kala Azar diagnosis) -All KA cases that have been previously treated with one of three regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin, Ambisome and Miltefosine combination over period Aug 2012 to Oct 2014 in pilot implementation study -Written voluntary informed consent to participate in the study.
排除标准
- •Patients who are unwilling to participate in the study or guardian/Legal Acceptable Representative unwilling to provide written informed consent will be excluded from the study.
结局指标
主要结局
To determine the prevalence rate of Post Kala Azar Dermal Leishmaniasis (PKDL) during or more than 24 months post treatment in Kala Azar treated cases with any of the three treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 days
时间窗: Follow up of VL patients treated earlier for atleast 24 months after receiving VL treatment
次要结局
- To determine the average time of occurrence of PKDL after each treatment(Follow up of patients for atleast 24 months)
- To compare occurrence of PKDL in different treatment arms(Follow up of treated patients for atleast 24 months)