Condition category
Infections and Infestations
Date applied
01/10/2007
Date assigned
01/10/2007
Last edited
01/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.icmr.nic.in/

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

Publication citations

Additional files

Editorial Notes