Sodium Stibogluconate (SSG) and Paromomycin Combination Compared to SSG for Visceral Leishmaniasis in East Africa: A Randomised Controlled Trial
Abstract
Visceral leishmaniasis (VL) is a parasitic disease with about 500,000 new cases each year and is fatal if untreated. The current standard therapy involves long courses, has toxicity and there is evidence of increasing resistance. New and better treatment options are urgently needed. Recently, the antibiotic paromomycin (PM) was tested and registered in India to treat this disease, but the same dose of PM monotherapy evaluated and registered in India was not efficacious in Sudan. This article reports the results of a clinical trial to test the effectiveness of injectable PM either alone (in a higher dose) or in combination with sodium stibogluconate (SSG) against the standard SSG monotherapy treatment in four East African countries - Sudan, Kenya, Ethiopia and Uganda. The study showed that the combination of SSG and PM was as efficacious and safe as the standard SSG treatment, with the advantages of being cheaper and requiring only 17 days rather than 30 days of treatment. In March 2010, a WHO Expert Committee recommended the use of the SSG and PM combination as a first line treatment for VL in East Africa.
Citation
Musa, A.; Khalil, E.; Hailu, A.; Olobo, J.; Balasegaram, M.; Omollo, R.; Edwards, T.; Rashid, J.; Mbui, J.; Musa, B.; Abuzaid, A.A.; Ahmed, O.; Fadlalla, A.; El-Hassan, A.; Mueller, M.; Mucee, G.; Njoroge, S.; Manduku, V.; Mutuma, G.; Apadet, L.; Lodenyo, H.; Mutea, D.; Kirigi, G.; Yifru, S.; Mengistu, G.; Hurissa, Z.; Hailu, W.; Weldegebreal, T.; Tafes, H.; Mekonnen, Y.; Makonnen, E.; Ndegwa, S.; Sagaki, P.; Kimutai, R.; Kesusu, J.; Owiti, R.; Ellis, S.; Wasunna, M. Sodium Stibogluconate (SSG) and Paromomycin Combination Compared to SSG for Visceral Leishmaniasis in East Africa: A Randomised Controlled Trial. PLoS Neglected Tropical Diseases (2012) 6 (6) e1674. [DOI: 10.1371/journal.pntd.0001674]