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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: Study protocol for a randomized controlled trial
Trials, Volume 12, Article 166, Year 2011
Notification
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Description
Background: Treatment options for Visceral Leishmaniasis (VL) in East Africa are far from satisfactory due to cost, toxicity, prolonged treatment duration or emergence of parasite resistance. Hence there is a need to explore alternative treatment protocols such as miltefosine alone or in combinations including miltefosine, sodium stibogluconate (SSG) or liposomal amphotericin B. The aim of this trial is to identify regimen(s) which are sufficiently promising for future trials in East Africa.Methods/Design: A phase II randomized, parallel arm, open-labelled trial is being conducted to assess the efficacy of each of the three regimens: liposomal amphotericin B with SSG, Liposomal amphotericin B with miltefosine and miltefosine alone. The primary endpoint is cure at day 28 with secondary endpoint at day 210 (6 months). Initial cure is a single composite measure based on parasitologic evaluation (bone marrow, spleen or lymph node aspirate) and clinical assessment. Repeated interim analyses have been planned after recruitment of 15 patients in each arm with a maximum sample size of 63 for each. These will follow group-sequential methods (the triangular test) to identify when a regimen is inadequate (<75% efficacy) or adequate (>90% efficacy). We describe a method to ensure consistency of the sequential analysis of day 28 cure with the non-sequential analysis of day 210 cure.Discussion: A regimen with adequate efficacy would be a candidate for treatment of VL with reasonable costs. The design allows repeated testing throughout the trial recruitment period while maintaining good statistical properties (Type I & II error rates) and reducing the expected sample sizes.Trial Registration: ClinicalTrials.gov: NCT01067443. © 2011 Omollo et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Omollo, Raymond
Unknown Affiliation
Alexander, Neal Douglas Edward
Unknown Affiliation
Edwards, Tansy
Unknown Affiliation
Khalil, Eltahir Awad Gasim
Unknown Affiliation
Younis, Brima Musa
Unknown Affiliation
Abuzaid, Abuzaid A.
Unknown Affiliation
Wasunna, Monique K.
Unknown Affiliation
Njoroge, Njenga
Unknown Affiliation
Kinoti, D.
Unknown Affiliation
Kirigi, George
Unknown Affiliation
Dorlo, Thomas P.C.
Unknown Affiliation
Ellis, Sally J.
Unknown Affiliation
Balasegaram, Manica
Unknown Affiliation
Musa, Ahmed Mudawi
Unknown Affiliation
Statistics
Citations: 52
Authors: 14
Affiliations: 7
Identifiers
Doi:
10.1186/1745-6215-12-166
e-ISSN:
17456215
Study Approach
Quantitative
Study Locations
Multi-countries