Study design and participants
abnormal liver function, allergy, infection, hearing loss, hypersensitivity
DISEASE, ALLERGY, INFECTION, HEARING LOSS, SKIN DISEASES, HYPERSENSITIVITY, SEVERE MALNUTRITION
This open-label, phase II, randomized, parallel-arm, non-comparative trial was conducted at the Professor El-Hassan Centre for Tropical Medicine, Doka, Sudan. Patients were randomized to one of two arms: PM for 14 days with MF for 42 days (arm 1) or LAmB for 7 days with MF for 28 days (arm 2). Patients aged 6 to ≤ 60 years with documented stable or progressive disease for at least 6 months or grade 3 PKDL, confirmed by clinical presentation and demonstration of parasites in a skin smear by microscopy or polymerase chain reaction (PCR), were included. Women of childbearing potential were eligible to participate but were required to use contraception from the beginning of the treatment period until 5 months after the end of treatment. Exclusion criteria included receiving treatment for PKDL within the last year; being pregnant or lactating; signs and symptoms of severe disease (concomitant severe infection or any other serious known underlying disease); severe malnutrition; haemoglobin <5 g/dL; other skin diseases; abnormal liver function (alanine aminotransferase and aspartate aminotransferase tests >3 x normal range); total bilirubin levels >1.5 times the upper normal range; serum creatinine above the upper limit of normal range; serum potassium <3.5 mmol/L; pre-existing clinical hearing loss based on audiometry at baseline; history of allergy or hypersensitivity to one of the study drugs; and being on immunomodulatory therapy. Data on the sex of participants was collected based on self-report. No difference in treatment efficacy was expected between male and female patients.