Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

Launched by BANARAS HINDU UNIVERSITY · Sep 5, 2006

Keywords

ClinConnect Summary

Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).

At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.

Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-6...

Gender

ALL

Eligibility criteria

• 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