FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/08/007190 [Registered on: 17/08/2016] Trial Registered Retrospectively
Last Modified On: 09/04/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Combination of oral and intravenous drugs for treatment of kala-azar in India 
Scientific Title of Study   Combination chemotherapy against visceral leishmaniasis: Comparative evaluation between miltefosine for 4 weeks and 2 weeks miltefosine combined with single dose liposomal amphotericin B in a tertiary care centre in Kolkata 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rama Prosad Goswami 
Designation  Professor, Department of Tropical Medicine 
Affiliation  School of Tropical Medicine, Kolkata, India 
Address  108, Chittaranjan Avenue, Kolkata, West Bengal, PIN 700073, India

Kolkata
WEST BENGAL
700073
India 
Phone  9432586945  
Fax    
Email  drrpgoswami@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Prosad Goswami 
Designation  Professor, Department of Tropical Medicine 
Affiliation  School of Tropical Medicine, Kolkata, India 
Address  108, Chittaranjan Avenue, Kolkata, West Bengal, PIN 700073, India

Kolkata
WEST BENGAL
700073
India 
Phone  9432586945  
Fax    
Email  drrpgoswami@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sukhen Das 
Designation  Senior Resident, Department of Tropical Medicine 
Affiliation  School of Tropical Medicine, Kolkata, India 
Address  108, Chittaranjan Avenue, Kolkata, West Bengal, PIN 700073, India

Kolkata
WEST BENGAL
700073
India 
Phone    
Fax    
Email  sukhen.cmc@gmail.com  
 
Source of Monetary or Material Support  
1)Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India - Infrastructure support 2)Lifecare Innovations Pvt Ltd, A-13, Iris Tech Park, Sector 48, Sohna Road, Gurgaon, Haryana- 122018,INDIA - supplied Liposomal Amphotericin B (Fungisome) free of cost 
 
Primary Sponsor  
Name  Dr Rama Prosad Goswami 
Address  Department of Tropical Medicine, 108, Chittaranjan Avenue, Kolkata, West Bengal, India, PIN 700073 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Lifecare Innovations Pvt Ltd  A-13, Iris Tech Park, Sector 48, Sohna Road, Gurgaon, Haryana- 122018, INDIA. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Rama Prosad Goswami  Calcutta School of Tropical Medicine, Department of Tropical Medicine, Room No: 20  Room No 20, Department of Tropical Medicine, 108, Chittaranjan Avenue, Kolkata, West Bengal, India, PIN 700073
Kolkata
WEST BENGAL 		 9432586945

drrpgoswami@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, School of Tropical Medicine, Kolkata (Institutional Ethics Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Treament of Visceral Leishmaniasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination therapy (Group B)  Liposomal Amphotericin B single dose (FUNGISOME TM single dose of 7.5 mg / Kg body weight infused in normal saline at a rate of 100mg/100 ml/hour) followedc by miltefosine (50mg twice daily (body weight more than 25 Kg) or 50 mg once daily (body weight less than 25Kg)) for 14 days  
Comparator Agent  Miltefosine monotherapy (group A)  Miltefosine monotherapy for 28 days at doses of 50mg twice daily (body weight more than 25 Kg) or 50 mg once daily (body weight less than 25Kg) 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with corroborative clinical history (prolonged fever not responding to antimalarials or antibiotics) and physical signs (anaemia, splenomegaly, hepatomegaly) with presence of parasites (LD bodies) confirmed by examination of Giemsa stained slides of splenic or bone marrow aspirates were enrolled into the study.
Confirmed visceral leishmaniasis patients who are fully informed about the risk of treatment and who signed the consent form themselves or by authorised relatives in their languages , will be included in the study group  
 
ExclusionCriteria 
Details  HIV positive individuals, Infant and children with body weight < 10Kgs, severe concurrent illnesses, receipt of any antileishmanial drugs or antifungal drugs in the previous 45 days, pregnancy and withdrawal of contraceptive measure. Patients with known hypersensitivity to the study drugs and those with diabetes, hypertension, or tuberculosis were also excluded. All patients with known heart, liver or kidney disease were excluded from the study. patients with renal function tests (serum creatinine) outside the normal range, liver function tests (transaminases) more than three times upper limit of the normal at study entry, Jaundice (bilirubin > 2.0mg/dL), Known hepatitis B or C positive, Platelet count less than 40,000/mm3, Prothrombin time 5 seconds or greater than normal range, Total WBC < 1,000/mm3, known alcohol or other drug abuse,concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc, concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days were excluded. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Clinical : fever , Spleen size, Anaemia, appetite, Body weight
2. Parasitological : Spleen/ Bone marrow smear  		 1. Clinical : end of treatment, at 6 months of follow - up and 2 - 4 years of follow up
2. Parasitological: End of treatment, at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Drug related adverse effects (Common Terminology Criteria for Adverse Events version 3.0)  Throughout treatement duration and at six months  
 
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   N/A 
Date of First Enrollment (India)
Modification(s)  		 11/01/2010 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/01/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   India is burdened with approximately 50,000 annual cases of Kala azar/visceral leismaniasis (VL). Visceral leishmaniasis remains invariably fatal untreated. With widespread resistance to pentavalent antimony, the conventional first line drug, oral miltefosine and injectable amphotericin B has become standard of care. Miltefosine is resistance prone when used singly and amphotericn B is potentially toxic and requires prolonged regimens of infusions. Recently the liposomal preparation of amphotericin B has improved management outcome through lower toxicity and shorter duration of therapy. In this proposed study we would like to compare the two regimens namely miltefosine monotherpay for 4 weeks which is standard NVBDCP recommendation in India and combination chemotherapy with single dose liposomal amphotericn B followed by miltefosine for 2 weeks.

 
Close