Visceral leishmaniasis Infections and Infestations Visceral leishmaniasis
Conditions
Interventions
Liposomal amphotericin B (one injection of 5 mg/kg) then miltefosine for 14 days.
Contact information for Principal Investigators:
Centre I:
Dr Shyam S
Sponsors
Indian Council of Medical Research (ICMR) (India)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
India
Outcome results
None listed