The efficacy and safety of a short course of miltefosine and liposomal amphotericin B for visceral leishmaniasis in India
| ISRCTN | ISRCTN99822704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99822704 |
| ClinicalTrials.gov number | NCT00371995 |
| Secondary identifying numbers | LEI PDE 0603 |
- Submission date
- 01/10/2007
- Registration date
- 01/10/2007
- Last edited
- 05/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Juntra Karbwang-Laothavorn
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3867 |
|---|---|
| karbwangj@who.int |
Study information
| Study design | Open multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The efficacy and safety of a short course of miltefosine and liposomal amphotericin B for visceral leishmaniasis in India |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Miltefosine, liposomal amphotericin B |
| Primary outcome measure | 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 study start date | 12/09/2007 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 135 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/09/2007 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
Indian Council of Medical Research (ICMR) (India)
Research council
Research council
V. Ramalingaswami Bhawan
Ansari Nagar
New Delhi
110029
India
| Website | http://www.icmr.nic.in/ |
|---|---|
"ROR" |
https://ror.org/0492wrx28 |
Funders
Funder type
Research organisation
Indian Council of Medical Research (ICMR) (India)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Zentaris GmbH (Germany)
No information available
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/12/2010 | 05/08/2021 | Yes | No |
Editorial Notes
05/08/2021: Publication reference, total final enrolment and ClinicalTrials.gov number added.
