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CTRI Number  CTRI/2018/05/014015 [Registered on: 21/05/2018] Trial Registered Retrospectively
Last Modified On: 17/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Safety and effectiveness of Liposomal Amphotericin B (AmBisome) Vs Miltefosine in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL) 
Scientific Title of Study   Assessment of Safety,efficacy of Liposomal Amphotericin B (AmBisome) Vs Miltefosine 12 weeks therapy in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL)-an observational pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKrishna Pandey 
Designation  Scientist-F 
Affiliation  Clinical Medicine, RMRIMS 
Address  Rajendra Memorial Research Institute of Medical Sciences(RMRIMS), Agamkuan, Patna

Patna
BIHAR
800007
India 
Phone    
Fax    
Email  drkrishnapandey@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKrishna Pandey 
Designation  Scientist-F 
Affiliation  Clinical Medicine, RMRIMS 
Address  Rajendra Memorial Research Institute of Medical Sciences(RMRIMS), Agamkuan, Patna

Patna
BIHAR
800007
India 
Phone    
Fax    
Email  drkrishnapandey@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrKrishna Pandey 
Designation  Scientist-F 
Affiliation  Clinical Medicine, RMRIMS 
Address  Rajendra Memorial Research Institute of Medical Sciences(RMRIMS), Agamkuan, Patna

Patna
BIHAR
800007
India 
Phone    
Fax    
Email  drkrishnapandey@yahoo.com  
 
Source of Monetary or Material Support  
RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES  
 
Primary Sponsor  
Name  RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES  
Address  RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES AGAMKUAN PATNA - 800007  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna Pandey  Rajendra Memorial Research Institute of Medical Sciences  Department of Clinical medicine, Agamkuan
Patna
BIHAR 
9431042119
0612-2634379
drkrishnapandey@yahoo.com 
DrKrishna Pandey  Rajendra Memorial Research Institute of Medical Sciences  Department of Clinical Medicine, Agamkuan
Patna
BIHAR 
9431042119

drkrishnapandey@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajendra Memorial Research Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post Kalaazar Dermal Leishmaniasis(PKDL),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liposomal Amphotericin B(AmBisome)  AmBisome at a total dose of 30 mg/kg, 5 mg/kg biweekly for 3 weeks 
Comparator Agent  Miltefosine   Miltefosine in the dose of 2.5mg/kg/day or 100mg/day for 12 weeks. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male or female patients aged 5- 65 years
Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis.
Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies and qPCR)
 
 
ExclusionCriteria 
Details  Pregnant and lactating female
Patients not willing to participate.
Thrombocyte count <100 x 1000000000/l
Leukocyte count <2.5 x 1000000000/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 AmBisome or inactive ingredients of AmBisome and Miltefosine.
Patients not willing to take contraceptive measures during study duration.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.
 
To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the adverse events and serious adverse events of the two different regimens
To assess the rates of relapse after initial response
To evaluate the biochemical and haematological parameters during the course of treatment.
 
12 months after the end of treatment. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/03/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

PKDL is a dermal form of leishmaniasis caused by protozoal parasite Leishmania donovani, spread through the bite of infected female Phlebotomine sand flies. It is characterized by macular, papular, or nodular lesions or a mixture of these. There are very limited drugs available for the treatment of PKDL.The present treatment guideline includes miltefosine in the dose of 2.5mg/kg/day or 100mg/day for 12 weeks. However, this drug is associated with gastrointestinal side effects and contraindicated in pregnant and nourishing women due to its teratogenic effect.  Recently a study by Ramesh et. al reported that the efficacy of miltefosine is decreasing substantially in the treatment of PKDL with a cure rate of 85%.  The other alternative treatment is with amphotericin B in the dose of 1mg/kg in 5% dextrose IV, alternate days for 15 injections in 3 to 4 courses at fifteen days intervals .This treatment regimen is very lengthy, requires prolonged hospitalization and has severe side effects including nephrotoxicity and hypokalemia. Liposomal formulation of amphotericin B has a longer half life, less toxic and recommended by WHO for elimination of VL from the Indian subcontinent. Liposomal amphotericin B at 2.5mg/kg for 20 days was tried in Sudanese PKDL.Cure rate was 83% and no adverse events were reported, Similarly a study was done in Bangladesh  with Ambisome by MSF(unpublished). Despite  high endemicity of the disease in India no study was done on PKDL with Ambisome. Therefore, we aimed to assess the efficacy and safety of Liposomal Amphotericin B in the treatment of PKDL in Bihar and compare it with the standard treatment of PKDL with Miltefosine 2.5 mg/kg body weight or 100 mg/day for 12 weeks. This study can proved to be one of the benchmark for establishing an effective, safe and shorter duration treatment for PKDL in the Indian subcontinent, which in turn will be of great help for the kalaazar elimination program.

 
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