| Autor: |
Musa, Ahmed M, Mbui, Jane, Mohammed, Rezika, Olobo, Joseph, Ritmeijer, Koert, Alcoba, Gabriel, Ouattara, Gina Muthoni, Egondi, Thaddaeus, Nakanwagi, Prossy, Omollo, Truphosa, Wasunna, Monique, Verrest, Luka, Dorlo, Thomas P C, Younis, Brima Musa, Nour, Ali, Elmukashfi, Elmukashfi Taha Ahmed, Haroun, Ahmed Ismail Omer, Khalil, Eltahir A G, Njenga, Simon, Fikre, Helina |
| Předmět: |
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| Zdroj: |
Clinical Infectious Diseases; 2/1/2023, Vol. 76 Issue 3, pe1177-e1185, 9p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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