Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial.
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Musa Ahmed, Khalil Eltahir, Hailu Asrat, Olobo Joseph, Balasegaram Manica, Omollo Raymond, Edwards Tansy, Rashid Juma, Mbui Jane, Musa Brima, Abuzaid Abuzaid Abdalla, Ahmed Osama, Fadlalla Ahmed, El-Hassan Ahmed, Mueller Marius, Mucee Geoffrey, Njoroge Simon, Manduku Veronica, Mutuma Geoffrey, Apadet Lilian, Lodenyo Hudson, Mutea Dedan, Kirigi George, Yifru Sisay, Mengistu Getahun, Hurissa Zewdu, Hailu Workagegnehu, Weldegebreal Teklu, Tafes Hailemariam, Mekonnen Yalemtsehay, Makonnen Eyasu, Ndegwa Serah, Sagaki Patrick, Kimutai Robert, Kesusu Josephine, Owiti Rhoda, Ellis Sally, Wasunna Monique
Аннотация
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.