University of Khartoum

Single-Dose Liposomal Amphotericin B (Ambisome®) for the Treatment of Visceral Leishmaniasis in East Africa: Study Protocol for a Randomized Controlled Trial

Single-Dose Liposomal Amphotericin B (Ambisome®) for the Treatment of Visceral Leishmaniasis in East Africa: Study Protocol for a Randomized Controlled Trial

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dc.contributor.author Khalil, Eltahir Awad G
dc.contributor.author Edwards, Tansy
dc.contributor.author Musa, Ahmed M.
dc.contributor.other Molecular Biology en_US
dc.date 2011
dc.date.accessioned 2015-11-29T08:03:36Z
dc.date.available 2015-11-29T08:03:36Z
dc.date.issued 2015-11-29
dc.date.submitted 2015
dc.identifier.uri http://khartoumspace.uofk.edu/123456789/17329
dc.description.abstract Background: AmBisome® 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 AmBisome®. Patients in the single-dose arm will receive one infusion on day 1, at a dose depending on body weight. For the first group of patients entered to the trial, the dose will be 7.5 mg/kg, but if this dose is found to be ineffective then in subsequent patient series the dose will be escalated progressively to 10, 12.5 and 15 mg/kg. Patients in the reference arm will receive a multi-dose regimen of AmBisome® (3 mg/kg/day on days 1-5, 14 and 21: total dose 21 mg/kg). Patients 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 patients 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 patients per arm. The final noninferiority analysis will include 120 patients 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. en_US
dc.language.iso en en_US
dc.publisher UOFK en_US
dc.subject Treatment en_US
dc.subject Visceral Leishmaniasis en_US
dc.subject East Africa en_US
dc.subject Randomized Controlled Trial en_US
dc.subject Single-Dose Liposomal Amphotericin en_US
dc.title Single-Dose Liposomal Amphotericin B (Ambisome®) for the Treatment of Visceral Leishmaniasis in East Africa: Study Protocol for a Randomized Controlled Trial en_US
dc.type Publication en_US
dc.Faculty Endemic Diseases en_US

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