Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis

Summary

The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.

Timeline

Start

2004-11

Primary completion

2010-01

Completion

2010-01

Outcome

Mixed primary results

paper 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). PMID 22724029 ↗

paper 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). PMID 22724029 ↗

Publications

• Musa A, Khalil E, Hailu A, Olobo J, Balasegaram M, Omollo R, Edwards T, Rashid J, Mbui J, Musa B, Abuzaid AA, Ahmed O, Fadlalla A, El-Hassan A, Mueller M, Mucee G, Njoroge S, Manduku V, Mutuma G, Apadet L, Lodenyo H, Mutea D, Kirigi G, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tafes H, Mekonnen Y, Makonnen E, Ndegwa S, Sagaki P, Kimutai R, Kesusu J, Owiti R, Ellis S, Wasunna M. Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. PLoS Negl Trop Dis. 2012;6(6):e1674. doi: 10.1371/journal.pntd.0001674. Epub 2012 Jun 19.
• Musa AM, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E. Paromomycin for the treatment of visceral leishmaniasis in Sudan: a randomized, open-label, dose-finding study. PLoS Negl Trop Dis. 2010 Oct 26;4(10):e855. doi: 10.1371/journal.pntd.0000855.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paromomycin	Small molecule	15 mg/kg	—
Subject	Paromomycin	Small molecule	20 mg/kg	—
Comparator	sodium stibogluconate	Unknown	20 mg/kg	—

Indications