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CTRI Number  CTRI/2016/06/007020 [Registered on: 13/06/2016] Trial Registered Prospectively
Last Modified On: 12/12/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To determine the occurrence of Post Kala-Azar Dermal Leishmaniasis (PKDL) in Visceral Leishmaniasis (VL) patients treated with new treatments in Bihar 
Scientific Title of Study   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 
Secondary IDs if Any  
Secondary ID  Identifier 
PKDL 24 MONTH FU 2015, version 19 December 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Das  
Designation  Director  
Affiliation  Rajendra Memorial Research Institute of Medical Sciences  
Address  Rajendra Memorial Research Institute of Medical Sciences, (Indian Council of Medical Research) Agam Kuan, Patna Patna BIHAR 800 007 India

Patna
BIHAR
800 007
India 
Phone  0612-2636651  
Fax  0612-2634379  
Email  drpradeep.das@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishal Goyal 
Designation  Clinical Manager 
Affiliation  Drugs for Neglected Diseases initiative  
Address  Drugs for Neglected Diseases initiative, PHD Chambers, 4/2 Siri Institutional Area

New Delhi
DELHI
110016
India 
Phone  91-11-45501795  
Fax    
Email  vgoyal@dndi.org  
 
Details of Contact Person
Public Query
 
Name  Dr Suman Rijal 
Designation  Head - Regional Office 
Affiliation  Drugs for Neglected Diseases initiative  
Address  Drugs for Neglected Diseases initiative, PHD Chambers, 4/2 Siri Institutional Area

New Delhi
DELHI
110016
India 
Phone  01145501795  
Fax    
Email  srijal@dndi.org  
 
Source of Monetary or Material Support  
Drugs for Neglected Diseases initiative (DNDi)  
 
Primary Sponsor  
Name  Drugs for Neglected Diseases initiative DNDi  
Address  15, Chemin Louis-Dunant, 1202, Geneva-Switzerland 
Type of Sponsor  Other [Not for Profit Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V N R Das  Rajendra Memorial Research Institute of Medical Sciences   Deputy Director (Scientist F) Rajendra Memorial Research Institute of Medical Sciences, (Indian Council of Medical Research) Agam Kuan, Patna Patna BIHAR - 800007
Patna
BIHAR 
9431646332

drvnrdas@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajendra Memorial Research Institute of Medical Sciences Ethic Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Visceral Leishmaniasis (VL), also known as Kala Azar and Post Kala Azar Dermal Leishmaniasis patients ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -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
 
 
ExclusionCriteria 
Details  -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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  Follow up of VL patients treated earlier for atleast 24 months after receiving VL treatment 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="1761"
Sample Size from India="1761" 
Final Enrollment numbers achieved (Total)= "1622"
Final Enrollment numbers achieved (India)="1622" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/06/2016 
Date of Study Completion (India) 31/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

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

 
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