| 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
|
|
|
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
|
|
|
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.
|
|
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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. |