Contact information
Type
Scientific
Primary contact
Prof Juntra Karbwang-Laothavorn
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3867
karbwangj@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LEI PDE 0603
Study information
Scientific title
Acronym
Study hypothesis
Visceral Leishmaniasis (VL) is a parasitological infection caused by Leishmania parasites that infect the reticulo-endothelial system and cause hepato-splenomegaly with pancytopenia. if untreated, there is a mortality rate of almost 100%. Most patients die from intercurrent infections.
Hypothesis:
To evaluate the efficacy and safety of a short course of liposomal amphotericin B in combination with miltefosine for the treatment of visceral leishmaniasis in India.
Ethics approval
Ethics approval received from:
1. World Health Organization research Ethics Review Committee (WHO ERC) on the 13th July 2007 (ref: RPC 209)
2. Ethics Committee of Rajendra Memorial Research Institute of Medical Sciences (RMRI-ICMR) on the 14th August 2007
3. Ethics Committee of Kala Azar Medical Research centre-Muzzaffarpur on the 18th August 2007
Study design
Open multicentre clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Visceral leishmaniasis
Intervention
Liposomal amphotericin B (one injection of 5 mg/kg) then miltefosine for 14 days.
Contact information for Principal Investigators:
Centre I:
Dr Shyam Sundar
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221 005
India
Tel: + 91 (0)542 2309493
Email: drshyamsundar@hotmail.com
Centre II:
Dr Prabhat Kumar Sinha
Rajendra Memorial Research Institute of Medical Sciences, Agamkuan
Patna 800 007
India
Tel: + 91 (0)612 641 565
Fax: + 91 (0)612 644 379
Email: pksinha18@yahoo.com
Joint Sponsor information:
Zentaris GmbH (Germany)
Weismuellerstr. 50
Frankfurt am Main, D-60314
Germany
Tel: + 49 (0)69 42602 3429
Fax: + 49 (0)69 42602 3404
Email: info@zentaris.com
Website: http://www.zentaris.com
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Avenue Appia 20
Geneva-27, CH-1211
Switzerland
Tel: + 41 (0)22 791 3725
Fax: + 41 (0)22 791 4854
Email: tdr@who.int
Wabsite: http://www.who.int/tdr
Intervention type
Drug
Phase
Not Specified
Drug names
Miltefosine, liposomal amphotericin B
Primary outcome measures
1. Final cure rate (initial parasitological cure rate based on splenic or bone marrow aspirate and clinical assessment at 6 months after end of treatment)
2. Initial cure rate (initial parasitological cure rate based on splenic or bone marrow aspirate, and clinical response at end of treatment)
3. Adverse events
Secondary outcome measures
No secondary outcome measures
Overall trial start date
12/09/2007
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female of age between 2 and 65 years (inclusive)
2. Clinical signs and symptoms compatible with Kala Azar (e.g., fever, splenomegaly, anaemia, leucopenia)
3. Confirmed diagnosis of VL by visualisation of parasites on splenic/bone marrow aspirate
4. Written informed consent from the patient/or from parent or guardian if under 18 years old
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Haemoglobin less than 6 g/dl
2. White blood cell count less than 1000/mm^3
3. Platelets less than 50,000
4. Prothrombin time greater than 5 seconds above control
5. Aspartate Aminotransferase (ASAT) greater than three times the upper limit of normal
6. Serum creatinine or Blood-Urea Nitrogen (BUN) greater than 1.5 times the upper limit of normal
7. Malaria
8. Human Immunodeficiency Virus (HIV) positive serology
9. Tuberculosis
10. Lactation, pregnancy
11. Refusing contraception method during treatment period plus 3 months
12. Any concomitant drug that is nephrotoxic
13. Previous treatment with amphotericin B or miltefosine. Previous treatment with antimony or paramomycin, if the treatment ended at least 2 months prior and the patient is clinically worsening, is permitted
14. Post Kala-azar Dermal Leishmaniasis (PKDL)
15. Concomitant treatment with other anti-leishmanial drugs
16. Any condition which compromises ability to comply with the study procedures
Recruitment start date
12/09/2007
Recruitment end date
30/06/2008
Locations
Countries of recruitment
India
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
Indian Council of Medical Research (ICMR) (India)
Sponsor details
V. Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India
Sponsor type
Research council
Website
Funders
Funder type
Research organisation
Funder name
Indian Council of Medical Research (ICMR) (India)
Alternative name(s)
ICMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
India
Funder name
Zentaris GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) (ref: LEI PDE 0603)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary