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Sodium stibogluconate (ssg) & paromomycin combination compared to ssg for visceral leishmaniasis in east africa: A randomised controlled trial
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نویسنده
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musa a. ,khalil e. ,hailu a. ,olobo j. ,balasegaram m. ,omollo r. ,edwards t. ,rashid j. ,mbui j. ,musa b. ,abuzaid a.a. ,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.
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منبع
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plos neglected tropical diseases - 2012 - دوره : 6 - شماره : 6
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چکیده
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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.gov nct00255567. © 2012 musa et al.
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آدرس
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institute of endemic diseases,university of khartoum,khartoum, Sudan, institute of endemic diseases,university of khartoum,khartoum, Sudan, addis ababa university,addis ababa, Ethiopia, makerere university,kampala, Uganda, médecins sans frontières-holland,amsterdam,netherlands,drugs for neglected diseases initiative (dndi),geneva, Switzerland, drugs for neglected diseases initiative (dndi),geneva, Switzerland, mrc tropical epidemiology group,london school of hygiene and tropical medicine,london, United Kingdom, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, institute of endemic diseases,university of khartoum,khartoum, Sudan, institute of endemic diseases,university of khartoum,khartoum, Sudan, institute of endemic diseases,university of khartoum,khartoum, Sudan, faculty of medicine,gedaref university,gedaref, Sudan, institute of endemic diseases,university of khartoum,khartoum, Sudan, médecins sans frontières-holland,amsterdam, Netherlands, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, centre for clinical research,kenya medical research institute,nairobi, Kenya, gondar university,gondar, Ethiopia, addis ababa university,addis ababa, Ethiopia, gondar university,gondar, Ethiopia, gondar university,gondar, Ethiopia, arba minch hospital,regional health bureau of snnpr state,arba minch, Ethiopia, arba minch hospital,regional health bureau of snnpr state,arba minch, Ethiopia, addis ababa university,addis ababa, Ethiopia, addis ababa university,addis ababa, Ethiopia, university of nairobi,nairobi, Kenya, amudat hospital,amudat, Uganda, drugs for neglected diseases initiative (dndi),geneva,switzerland,centre for clinical research,kenya medical research institute,nairobi, Kenya, drugs for neglected diseases initiative (dndi),geneva,switzerland,centre for clinical research,kenya medical research institute,nairobi, Kenya, drugs for neglected diseases initiative (dndi),geneva,switzerland,centre for clinical research,kenya medical research institute,nairobi, Kenya, drugs for neglected diseases initiative (dndi),geneva, Switzerland, drugs for neglected diseases initiative (dndi),geneva,switzerland,centre for clinical research,kenya medical research institute,nairobi, Kenya
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Authors
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