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Randomized Controlled Trial
. 2012;6(6):e1674.
doi: 10.1371/journal.pntd.0001674. Epub 2012 Jun 19.

Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial

Ahmed Musa  1 , 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
Affiliations
Randomized Controlled Trial

Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial

Ahmed Musa et al. PLoS Negl Trop Dis. 2012.

Abstract

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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Conflict of interest statement

The authors have read the journal's policy and have the following conflicts: Manica Balasegaram is employed by DNDi as Head of VL Clinical Program. Sally Ellis is employed by DNDi as Clinical Manager (VL). Robert Kimutai is employed by DNDi as a Clinical Trial Manager. Raymond Omollo works for DNDi. Marius Mueller works for MSF.

Figures

Figure 1
Figure 1. CONSORT Patient Flowchart – SSG vs. PM.
SSG, sodium stibogluconate; PM, paromomycin sulphate; SAE, serious adverse event; LTFU, loss to follow-up; ITT, intention-to-treat; PP, per protocol. Patients included in the SSG (20 mg/kg/day for 30 days) vs. PM (20 mg/kg/day for 21 days) arms; a data from these patients were previously reported .
Figure 2
Figure 2. CONSORT Patient Flowchart – SSG vs. SSG&PM.
SSG, sodium stibogluconate; PM, paromomycin sulphate; SAE, serious adverse event; LTFU, loss to follow-up; ITT, intention-to-treat; PP, per protocol. Patients included in the SSG (SSG at 20 mg/kg/day for 30 days) vs. SSG & PM combination (SSG at 20 mg/kg/day & PM at 15 mg/kg/day for 17 days) arms; a patient was diagnosed with tuberculosis and was removed from the study before the end of treatment; b patient died from non-VL causes; c patient with deviation also had a missing outcome value and was already excluded from the ITT analysis.
See this image and copyright information in PMC

References

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