Single-dose liposomal amphotericin B ( XXXX  ) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial.

@entity1 @entity24408
BACKGROUND: @entity24408   is an efficacious, safe anti-leishmanial treatment. There is growing interest in its use, either as a single dose or in combination treatments. In East Africa, the minimum optimal single-dosage has not been identified. METHODS/DESIGN: An open-label, 2-arm, non-inferiority, multi-centre randomised controlled trial is being conducted to determine the optimal single-dose treatment with @entity24408  . @entity1 in the single-dose arm will receive one infusion on day 1, at a dose depending on body weight. For the first group of @entity1 entered to the trial, the dose will be 7.5 mg/kg, but if this dose is found to be ineffective then in subsequent @entity1 series the dose will be escalated progressively to 10, 12.5 and 15 mg/kg. @entity1 in the reference arm will receive a multi-dose regimen of @entity24408   (3 mg/kg/day on days 1-5, 14 and 21: total dose 21 mg/kg). @entity1 will be hospitalised for approximately one month after the start of treatment and then followed up at three and six months. The primary endpoint is the status of @entity1 six months after treatment. A secondary endpoint is assessment at day 30. Treatment success is determined as the absence of parasites on microscopy samples taken from bone marrow, lymph node or splenic aspirates. Interim analyses to assess the comparative efficacy of the single dose are planned after recruitment of 20 and 40 @entity1 per arm. The final non-inferiority analysis will include 120 @entity1 per arm, to determine if the single-dose efficacy 6 months after treatment is not more than 10% inferior to the multi-dose. DISCUSSION: An effective, safe single-dose treatment would reduce hospitalization and treatment costs. Results will inform the design of combination treatment studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT00832208.
