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 ORCID logo; Juma Rashid; Jane Mbui; Brima Musa; +28 more... 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) Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. PLoS neglected tropical diseases, 6 (6). e1674-. ISSN 1935-2727 DOI: 10.1371/journal.pntd.0001674
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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.govNCT00255567.


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