Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial.
Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India.A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium...
Published in: | PLoS Neglected Tropical Diseases |
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2012
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ftdoajarticles:oai:doaj.org/article:43f9bae862404e6cb8fcfe11b1ee9d29 2023-05-15T15:12:25+02:00 Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. Ahmed Musa Eltahir Khalil Asrat Hailu Joseph Olobo Manica Balasegaram Raymond Omollo Tansy Edwards Juma Rashid Jane Mbui Brima Musa Abuzaid Abdalla Abuzaid Osama Ahmed Ahmed Fadlalla Ahmed El-Hassan Marius Mueller Geoffrey Mucee Simon Njoroge Veronica Manduku Geoffrey Mutuma Lilian Apadet Hudson Lodenyo Dedan Mutea George Kirigi Sisay Yifru Getahun Mengistu Zewdu Hurissa Workagegnehu Hailu Teklu Weldegebreal Hailemariam Tafes Yalemtsehay Mekonnen Eyasu Makonnen Serah Ndegwa Patrick Sagaki Robert Kimutai Josephine Kesusu Rhoda Owiti Sally Ellis Monique Wasunna 2012-01-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0001674 https://doaj.org/article/43f9bae862404e6cb8fcfe11b1ee9d29 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC3378617?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0001674 https://doaj.org/article/43f9bae862404e6cb8fcfe11b1ee9d29 PLoS Neglected Tropical Diseases, Vol 6, Iss 6, p e1674 (2012) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2012 ftdoajarticles https://doi.org/10.1371/journal.pntd.0001674 2023-01-08T01:28:23Z Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India.A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4-60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data.The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200 patients respectively. The SSG & PM versus SSG comparison enrolled 381 and 386 patients per arm respectively, with primary efficacy data available for 359 patients per arm. In Intention-to-Treat complete-case analyses, the efficacy of PM was significantly lower than SSG (84.3% versus 94.1%, difference = 9.7%, 95% confidence interval, CI: 3.6 to 15.7%, p = 0.002). The efficacy of SSG & PM was comparable to SSG (91.4% versus 93.9%, difference = 2.5%, 95% CI: -1.3 to 6.3%, p = 0.198). End of treatment efficacy results were very similar. There were no apparent differences in the safety profile of the three treatment regimens.The 17 day SSG & PM combination treatment had a good safety profile and was similar in efficacy to the standard 30 day SSG treatment, suggesting suitability for VL treatment in East Africa.www.clinicaltrials.govNCT00255567. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 6 6 e1674 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Ahmed Musa Eltahir Khalil Asrat Hailu Joseph Olobo Manica Balasegaram Raymond Omollo Tansy Edwards Juma Rashid Jane Mbui Brima Musa Abuzaid Abdalla Abuzaid Osama Ahmed Ahmed Fadlalla Ahmed El-Hassan Marius Mueller Geoffrey Mucee Simon Njoroge Veronica Manduku Geoffrey Mutuma Lilian Apadet Hudson Lodenyo Dedan Mutea George Kirigi Sisay Yifru Getahun Mengistu Zewdu Hurissa Workagegnehu Hailu Teklu Weldegebreal Hailemariam Tafes Yalemtsehay Mekonnen Eyasu Makonnen Serah Ndegwa Patrick Sagaki Robert Kimutai Josephine Kesusu Rhoda Owiti Sally Ellis Monique Wasunna Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India.A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4-60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data.The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200 patients respectively. The SSG & PM versus SSG comparison enrolled 381 and 386 patients per arm respectively, with primary efficacy data available for 359 patients per arm. In Intention-to-Treat complete-case analyses, the efficacy of PM was significantly lower than SSG (84.3% versus 94.1%, difference = 9.7%, 95% confidence interval, CI: 3.6 to 15.7%, p = 0.002). The efficacy of SSG & PM was comparable to SSG (91.4% versus 93.9%, difference = 2.5%, 95% CI: -1.3 to 6.3%, p = 0.198). End of treatment efficacy results were very similar. There were no apparent differences in the safety profile of the three treatment regimens.The 17 day SSG & PM combination treatment had a good safety profile and was similar in efficacy to the standard 30 day SSG treatment, suggesting suitability for VL treatment in East Africa.www.clinicaltrials.govNCT00255567. |
format |
Article in Journal/Newspaper |
author |
Ahmed Musa Eltahir Khalil Asrat Hailu Joseph Olobo Manica Balasegaram Raymond Omollo Tansy Edwards Juma Rashid Jane Mbui Brima Musa Abuzaid Abdalla Abuzaid Osama Ahmed Ahmed Fadlalla Ahmed El-Hassan Marius Mueller Geoffrey Mucee Simon Njoroge Veronica Manduku Geoffrey Mutuma Lilian Apadet Hudson Lodenyo Dedan Mutea George Kirigi Sisay Yifru Getahun Mengistu Zewdu Hurissa Workagegnehu Hailu Teklu Weldegebreal Hailemariam Tafes Yalemtsehay Mekonnen Eyasu Makonnen Serah Ndegwa Patrick Sagaki Robert Kimutai Josephine Kesusu Rhoda Owiti Sally Ellis Monique Wasunna |
author_facet |
Ahmed Musa Eltahir Khalil Asrat Hailu Joseph Olobo Manica Balasegaram Raymond Omollo Tansy Edwards Juma Rashid Jane Mbui Brima Musa Abuzaid Abdalla Abuzaid Osama Ahmed Ahmed Fadlalla Ahmed El-Hassan Marius Mueller Geoffrey Mucee Simon Njoroge Veronica Manduku Geoffrey Mutuma Lilian Apadet Hudson Lodenyo Dedan Mutea George Kirigi Sisay Yifru Getahun Mengistu Zewdu Hurissa Workagegnehu Hailu Teklu Weldegebreal Hailemariam Tafes Yalemtsehay Mekonnen Eyasu Makonnen Serah Ndegwa Patrick Sagaki Robert Kimutai Josephine Kesusu Rhoda Owiti Sally Ellis Monique Wasunna |
author_sort |
Ahmed Musa |
title |
Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
title_short |
Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
title_full |
Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
title_fullStr |
Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
title_full_unstemmed |
Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. |
title_sort |
sodium stibogluconate (ssg) & paromomycin combination compared to ssg for visceral leishmaniasis in east africa: a randomised controlled trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2012 |
url |
https://doi.org/10.1371/journal.pntd.0001674 https://doaj.org/article/43f9bae862404e6cb8fcfe11b1ee9d29 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 6, Iss 6, p e1674 (2012) |
op_relation |
http://europepmc.org/articles/PMC3378617?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0001674 https://doaj.org/article/43f9bae862404e6cb8fcfe11b1ee9d29 |
op_doi |
https://doi.org/10.1371/journal.pntd.0001674 |
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PLoS Neglected Tropical Diseases |
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6 |
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e1674 |
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