Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Sodium stibogluconate (ssg) & paromomycin combination compared to ssg for visceral leishmaniasis in east africa: A randomised controlled trial
PLoS Neglected Tropical Diseases, Volume 6, No. 6, Article e1674, Year 2012
Notification
URL copied to clipboard!
Description
Background: 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. Methods: 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. Findings: 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. Conclusion: 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. Clinical Trials Registration: www.clinicaltrials.gov NCT00255567. © 2012 Musa et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3378617/bin/pntd.0001674.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3378617/bin/pntd.0001674.s002.pdf
Authors & Co-Authors
Musa, Ahmed Mudawi
Unknown Affiliation
Khalil, Eltahir Awad Gasim
Unknown Affiliation
Hailu, Asrat
Unknown Affiliation
Olobo, Joseph Okao
Unknown Affiliation
Balasegaram, Manica
Unknown Affiliation
Omollo, Raymond
Unknown Affiliation
Edwards, Tansy
Unknown Affiliation
Rashid, Juma R.
Unknown Affiliation
Mbui, Jane K.
Unknown Affiliation
Musa, Brima Younis
Unknown Affiliation
Abuzaid, Abuzaid A.
Unknown Affiliation
Ahmed, Osama
Unknown Affiliation
Fadlalla, Ahmed
Unknown Affiliation
el-Hassan, Ahmed Mohamed A.
Unknown Affiliation
Mueller, Marius
Unknown Affiliation
Mucee, Geoffrey
Unknown Affiliation
Njoroge, Simon N.
Unknown Affiliation
Manduku, Veronica
Unknown Affiliation
Mutuma, G. Z.
Unknown Affiliation
Apadet, Lilian
Unknown Affiliation
Lodenyo, Hudson
Unknown Affiliation
Mutea, Dedan
Unknown Affiliation
Kirigi, George
Unknown Affiliation
Yifru, Sisay
Unknown Affiliation
Mengistu, Getahun
Unknown Affiliation
Hurissa, Zewdu
Unknown Affiliation
Hailu, Workagegnehu
Unknown Affiliation
Weldegebreal, Teklu
Unknown Affiliation
Tafes, Hailemariam
Unknown Affiliation
Mekonnen, Yalemtsehay
Unknown Affiliation
Makonnen, Eyasu
Unknown Affiliation
Ndegwa, Serah Nyambura
Unknown Affiliation
Sagaki, Patrick
Unknown Affiliation
Kimutai, Robert L.
Unknown Affiliation
Kesusu, J.
Unknown Affiliation
Owiti, Rhoda
Unknown Affiliation
Ellis, Sally J.
Unknown Affiliation
Wasunna, Monique K.
Unknown Affiliation
Statistics
Citations: 136
Authors: 38
Affiliations: 13
Identifiers
Doi:
10.1371/journal.pntd.0001674
ISSN:
19352727
e-ISSN:
19352735
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative
Study Locations
Multi-countries