Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial.
PLoS Negl Trop Dis
; 6(6): e1674, 2012.
Article
en En
| MEDLINE
| ID: mdl-22724029
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%, differenceâ=â9.7%, 95% confidence interval, CI 3.6 to 15.7%, pâ=â0.002). The efficacy of SSG & PM was comparable to SSG (91.4% versus 93.9%, differenceâ=â2.5%, 95% CI -1.3 to 6.3%, pâ=â0.198). 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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Paromomicina
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Gluconato de Sodio Antimonio
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Leishmaniasis Visceral
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Antiprotozoarios
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Africa
Idioma:
En
Revista:
PLoS Negl Trop Dis
Asunto de la revista:
MEDICINA TROPICAL
Año:
2012
Tipo del documento:
Article
País de afiliación:
Sudán