caa a22 4500 606155627 CHVBK 20210128100604.0 cr unu---uuuuu 210128e20150601xx s 000 0 eng 10.1007/s10096-015-2338-5 doi (NATIONALLICENCE)springer-10.1007/s10096-015-2338-5 A part-randomized study of intravenous oseltamivir in adolescents and adults [Elektronische Daten] [I. Várkonyi, C. Chappey, M. Giraudon, L. Burleigh] Seriously ill patients with influenza may be unable to take oral medication. The safety of intravenous oseltamivir was evaluated in adults and adolescents. This prospective, part-randomized study enrolled hospitalized patients aged ≥13years with clinical or laboratory-confirmed influenza, who started study medication within 144h of illness onset. Patients with normal renal function received oseltamivir 100 or 200mg every 12h for 5days by slow intravenous infusion. Patients with renal impairment received lower doses, appropriate to the degree of impairment. Blood samples were taken for pharmacokinetics, and nasal swabs were taken to monitor viral shedding and resistance [reverse transcription polymerase chain reaction (RT-PCR) and culture]. Adverse events (AEs) were monitored for 30days from treatment initiation. Of the 118 patients enrolled, 103 had normal renal function. On day 1, 64 patients had laboratory-confirmed influenza. Ninety-four (80%) patients completed 5days of oseltamivir treatment (32 intravenous only). Sixty-eight and 13 patients reported on-treatment AEs and serious AEs (SAEs), respectively (62 and nine during intravenous dosing, respectively). For 33 and six patients, these AEs and SAEs were considered treatment-related (31 and five during intravenous dosing, respectively); 11 patients had AEs causing treatment withdrawal. Five patients died. Adequate systemic exposure to oseltamivir carboxylate (OC) was achieved at the intravenous doses tested. Oseltamivir-resistant viruses (H275Y) were detected in two patients. In seriously ill, hospitalized patients with/without renal impairment, intravenous oseltamivir was not associated with adverse safety findings at the dosages tested and achieved systemic OC exposures at least as high as the approved oral dose. Springer-Verlag Berlin Heidelberg, 2015 Várkonyi I. ClinTrial Audit Ltd., Clinical Pharmacology Centre, Bartók B. 2-26, 4043, Debrecen, Hungary aut Chappey C. Genentech Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut Giraudon M. Roche Pharmaceutical Research and Early Development, Small Molecule Research, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070, Basel, Switzerland aut Burleigh L. Roche Products Ltd., Hexagon Place, 6 Falcon Way, Shire Park, AL7 1TW, Welwyn Garden City, UK aut European Journal of Clinical Microbiology & Infectious Diseases Springer Berlin Heidelberg 34/6(2015-06-01), 1181-1188 0934-9723 34:6<1181 2015 34 10096 https://doi.org/10.1007/s10096-015-2338-5 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10096-015-2338-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Várkonyi I. ClinTrial Audit Ltd., Clinical Pharmacology Centre, Bartók B. 2-26, 4043, Debrecen, Hungary aut NATIONALLICENCE 700 1- Chappey C. Genentech Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut NATIONALLICENCE 700 1- Giraudon M. Roche Pharmaceutical Research and Early Development, Small Molecule Research, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070, Basel, Switzerland aut NATIONALLICENCE 700 1- Burleigh L. Roche Products Ltd., Hexagon Place, 6 Falcon Way, Shire Park, AL7 1TW, Welwyn Garden City, UK aut NATIONALLICENCE 773 0- European Journal of Clinical Microbiology & Infectious Diseases Springer Berlin Heidelberg 34/6(2015-06-01), 1181-1188 0934-9723 34:6<1181 2015 34 10096