None listed
Conditions
Brief summary
The study is designed to determine the use of delivering treatment with liposomal amphotericin B (AmBisome) single dose of 10 mg/kg when administrated in the Upazila Health Complex settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment.
Interventions
Liposomal Amphotericin B (AmBisome), single dose of 10 mg/kg, administered by intravenous infusion, over a period of approximately 2 hours.
Sponsors
World Health Organization
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female patients 5 or more years of age History of fever for more than 2 weeks Splenomegaly rK 39 rapid test positive done by the study team Hemoglobin equal or greater than 5 g/dl
Exclusion criteria
A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions not under control before starting the treatment with liposomal amphotericin B (AmBisme). Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up A history of allergy or hypersensitivity to amphotericin B Previous treatment for VL within two months of enrolment into the study Prior treatment failure with amphotericin B
Outcome results
None listed