Visceral Leishmaniasis Clinical Trial
Official title:
The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
Verified date | September 2008 |
Source | Banaras Hindu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 2010 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male and female age between 2 and 65 years (inclusive) - Parasites visualized on splenic aspiration - Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia) - Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate - Fever for at least 2 weeks - Written informed consent from the patient/or from parent or guardian if under 18 years old Exclusion Criteria: - Hemoglobin < 6 g/dl - White blood cell count < 1000/mm3 - Platelets <50,000 - Prothrombin time > 5 sec above control - ASAT > 3 times the upper limit of normal - Serum creatinine or BUN > 1.5 times the upper limit of normal - Malaria - Tuberculosis - HIV positive serology - Lactation, pregnancy - Refusing contraception method during treatment period plus 3 months - Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs - Any concomitant drug that is nephrotoxic |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Kala-azar Medical Research Center | Muzaffarpur | Bihar |
India | Rajendra Memorial Research Institute of Medical Sciences | Patna | Bihar |
Lead Sponsor | Collaborator |
---|---|
Banaras Hindu University | Rajendra Memorial Research Institute of Medical Sciences |
India,
Sundar S, Sinha PK, Verma DK, Kumar N, Alam S, Pandey K, Kumari P, Ravidas V, Chakravarty J, Verma N, Berman J, Ghalib H, Arana B. Ambisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011 Feb;105(2):115-7. doi: 10.1016/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final Cure six months after the end of treatment | 1 year | Yes |
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