Post-kala-azar Dermal Leishmaniasis
Conditions
Keywords
Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis, AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar
Brief summary
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.
Detailed description
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.
Interventions
DRUGAmBisome
A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
Sponsors
Medecins Sans Frontieres, Netherlands
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)
Exclusion criteria
* PKDL and concurrent VL * Prior treatment for PKDL * On medication with a side effect profile overlapping with that of AmBisome * A known hypersensitivity to AmBisome * Pregnant and lactating women, * Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine \> 1.3 mg/dL) * Serum potassium \<3.5mmol/L at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final outcome | 12 months | The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 7 weeks | Adverse events and serious adverse events were recorded during and up to one month after treatment. |
| Hypokalaemia | 7 weeks | Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment. |
Outcome results
None listed