The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
280
A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
Final outcome
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
Time frame: 12 months
Safety
Adverse events and serious adverse events were recorded during and up to one month after treatment.
Time frame: 7 weeks
Hypokalaemia
Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.
Time frame: 7 weeks
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