| 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 |
| Trial Acronym |
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |