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> (2020-2022)
> (2022)
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Paromomycin and Mil...
Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa : A Randomized, Controlled, Multicountry Trial.
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Musa, Ahmed M (author)
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Mbui, Jane (author)
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Mohammed, Rezika (author)
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Olobo, Joseph (author)
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Ritmeijer, Koert (author)
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Alcoba, Gabriel (author)
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Muthoni Ouattara, Gina (author)
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Egondi, Thaddaeus (author)
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Nakanwagi, Prossy (author)
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Omollo, Truphosa (author)
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Wasunna, Monique (author)
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Verrest, Luka (author)
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- Dorlo, Thomas P. C. (author)
- Uppsala universitet,Institutionen för farmaci
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Musa Younis, Brima (author)
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Nour, Ali (author)
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Taha Ahmed Elmukashfi, Elmukashfi (author)
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Ismail Omer Haroun, Ahmed (author)
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Khalil, Eltahir A G (author)
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Njenga, Simon (author)
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Fikre, Helina (author)
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Mekonnen, Tigist (author)
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Mersha, Dagnew (author)
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Sisay, Kasaye (author)
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Sagaki, Patrick (author)
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Alvar, Jorge (author)
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Solomos, Alexandra (author)
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Alves, Fabiana (author)
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(creator_code:org_t)
- 2022
- 2022
- English.
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In: Clinical Infectious Diseases. - : Oxford University Press (OUP). - 1058-4838 .- 1537-6591.
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- BACKGROUND: This study aimed to determine whether paromomycin plus miltefosine (PM/MF) is noninferior to sodium stibogluconate plus paromomycin (SSG/PM) for treatment of primary visceral leishmaniasis in eastern Africa.METHODS: An open-label, phase 3, randomized, controlled trial was conducted in adult and pediatric patients at 7 sites in eastern Africa. Patients were randomly assigned to either 20 mg/kg paromomycin plus allometric dose of miltefosine (14 days), or 20 mg/kg sodium stibogluconate plus 15 mg/kg paromomycin (17 days). The primary endpoint was definitive cure after 6 months.RESULTS: Of 439 randomized patients, 424 completed the trial. Definitive cure at 6 months was 91.2% (155 of 170) and 91.8% (156 of 170) in the PM/MF and SSG/PM arms in primary efficacy modified intention-to-treat analysis (difference, 0.6%; 97.5% confidence interval [CI], -6.2 to 7.4), narrowly missing the noninferiority margin of 7%. In the per-protocol analysis, efficacy was 92% (149 of 162) and 91.7% (155 of 169) in the PM/MF and SSG/PM arms (difference, -0.3%; 97.5% CI, -7.0 to 6.5), demonstrating noninferiority. Treatments were well tolerated. Four of 18 serious adverse events were study drug-related, and 1 death was SSG-related. Allometric dosing ensured similar MF exposure in children (<12 years) and adults.CONCLUSIONS: PM/MF and SSG/PM efficacies were similar, and adverse drug reactions were as expected given the drugs safety profiles. With 1 less injection each day, reduced treatment duration, and no risk of SSG-associated life-threatening cardiotoxicity, PM/MF is a more patient-friendly alternative for children and adults with primary visceral leishmaniasis in eastern Africa. Clinical Trials Registration. NCT03129646.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- eastern Africa
- miltefosine
- paromomycin
- phase 3 trial
- visceral leishmaniasis
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Musa, Ahmed M
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Mbui, Jane
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Mohammed, Rezika
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Olobo, Joseph
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Ritmeijer, Koert
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Alcoba, Gabriel
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show more...
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Muthoni Ouattara ...
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Egondi, Thaddaeu ...
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Nakanwagi, Pross ...
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Omollo, Truphosa
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Wasunna, Monique
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Verrest, Luka
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Dorlo, Thomas P. ...
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Musa Younis, Bri ...
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Nour, Ali
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Taha Ahmed Elmuk ...
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Ismail Omer Haro ...
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Khalil, Eltahir ...
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Njenga, Simon
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Fikre, Helina
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Mekonnen, Tigist
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Mersha, Dagnew
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Sisay, Kasaye
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Sagaki, Patrick
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Alvar, Jorge
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Solomos, Alexand ...
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Alves, Fabiana
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
- Articles in the publication
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Clinical Infecti ...
- By the university
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Uppsala University