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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Geographical variation in the response of visceral leishmaniasis to paromomycin in East Africa: A multicentre, open-label, randomized trial
PLoS Neglected Tropical Diseases, Volume 4, No. 10, Article e709, Year 2010
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Description
Background: Visceral leishmaniasis (VL) is a major health problem in developing countries. The untreated disease is fatal, available treatment is expensive and often toxic, and drug resistance is increasing. Improved treatment options are needed. Paromomycin was shown to be an efficacious first-line treatment with low toxicity in India. Methods: This was a 3-arm multicentre, open-label, randomized, controlled clinical trial to compare three treatment regimens for VL in East Africa: paromomycin sulphate (PM) at 15 mg/kg/day for 21 days versus sodium stibogluconate (SSG) at 20 mg/kg/day for 30 days; and the combination of both dose regimens for 17 days. The primary efficacy endpoint was cure based on parasite-free tissue aspirates taken 6 months after treatment. Findings: Overall, 135 patients per arm were enrolled at five centres in Sudan (2 sites), Kenya (1) and Ethiopia (2), when the PM arm had to be discontinued due to poor efficacy. The trial has continued with the higher dose of PM as well as the combination of PM and SSG arms. These results will be reported later. Baseline patient characteristics were similar among treatment arms. The overall cure with PM was significantly inferior to that with SSG (63.8% versus 92.2%; difference 28.5%, 95%CI 18.8% to 38.8%, p<0.001). The efficacy of PM varied among centres and was significantly lower in Sudan (14.3% and 46.7%) than in Kenya (80.0%) and Ethiopia (75.0% and 96.6%). No major safety issues with PM were identified. Conclusion: The efficacy of PM at 15 mg/kg/day for 21 days was inadequate, particularly in Sudan. The efficacy of higher doses and the combination treatment warrant further studies. © 2010 Hailu et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2964287/bin/pntd.0000709.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC2964287/bin/pntd.0000709.s002.doc
Authors & Co-Authors
Hailu, Asrat
Unknown Affiliation
Musa, Ahmed Mudawi
Unknown Affiliation
Wasunna, Monique K.
Unknown Affiliation
Balasegaram, Manica
Unknown Affiliation
Yifru, Sisay
Unknown Affiliation
Mengistu, Getahun
Unknown Affiliation
Hurissa, Zewdu
Unknown Affiliation
Hailu, Workagegnehu
Unknown Affiliation
Weldegebreal, Teklu
Unknown Affiliation
Tesfaye, Samson
Unknown Affiliation
Makonnen, Eyasu
Unknown Affiliation
Khalil, Eltahir Awad Gasim
Unknown Affiliation
Ahmed, Osama
Unknown Affiliation
Fadlalla, Ahmed
Unknown Affiliation
el-Hassan, Ahmed Mohamed A.
Unknown Affiliation
Raheem, Muzamil A.
Unknown Affiliation
Mueller, Marius
Unknown Affiliation
Koummuki, Yousif
Unknown Affiliation
Rashid, Juma R.
Unknown Affiliation
Mbui, Jane K.
Unknown Affiliation
Mucee, Geoffrey
Unknown Affiliation
Njoroge, Simon N.
Unknown Affiliation
Manduku, Veronica
Unknown Affiliation
Musibi, Alice M.
Unknown Affiliation
Mutuma, G. Z.
Unknown Affiliation
Kirui, Fredrick K.
Unknown Affiliation
Lodenyo, Hudson
Unknown Affiliation
Mutea, Dedan
Unknown Affiliation
Kirigi, George
Unknown Affiliation
Edwards, Tansy
Unknown Affiliation
Smith, Peter
Unknown Affiliation
Muthami, Lawrence N.
Unknown Affiliation
Royce, Catherine
Unknown Affiliation
Ellis, Sally J.
Unknown Affiliation
Alobo, Moses
Unknown Affiliation
Omollo, Raymond
Unknown Affiliation
Kesusu, J.
Unknown Affiliation
Owiti, Rhoda
Unknown Affiliation
Kinuthia, John
Unknown Affiliation
Statistics
Citations: 123
Authors: 39
Affiliations: 10
Identifiers
Doi:
10.1371/journal.pntd.0000709
Research Areas
Environmental
Health System And Policy
Study Locations
Multi-countries
Ethiopia
Kenya
Sudan