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.FacultyEndemic Diseasesen_US
dc.contributor.authorKhalil, Eltahir Awad G
dc.contributor.authorEdwards, Tansy
dc.contributor.authorMusa, Ahmed M.
dc.contributor.authorRaymond Omollo
dc.contributor.authorSisay Yifru
dc.contributor.authorBrima Musa
dc.contributor.authorMonique Wasunna
dc.contributor.authorPeter G Smith
dc.contributor.authorCatherine Royce
dc.contributor.authorSally Ellis
dc.contributor.authorManica Balasegaram
dc.contributor.authorAsrat Hailu
dc.contributor.otherMolecular Biologyen_US
dc.date2011
dc.date.accessioned2015-11-29T08:03:36Z
dc.date.available2015-11-29T08:03:36Z
dc.date.issued2015-11-29
dc.date.submitted2015
dc.description.abstractBackground: 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.identifier.urihttp://khartoumspace.uofk.edu/123456789/17329
dc.language.isoenen_US
dc.publisherUOFKen_US
dc.subjectTreatmenten_US
dc.subjectVisceral Leishmaniasisen_US
dc.subjectEast Africaen_US
dc.subjectRandomized Controlled Trialen_US
dc.subjectSingle-Dose Liposomal Amphotericinen_US
dc.titleSingle-Dose Liposomal Amphotericin B (Ambisome®) for the Treatment of Visceral Leishmaniasis in East Africa: Study Protocol for a Randomized Controlled Trialen_US
dc.typePublicationen_US

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