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- Title
Three-day regimen of oseltamivir for post-exposure prophylaxis of influenza in hospital wards: a study protocol for a prospective, multi-center, single-arm trial.
- Authors
Ishiguro, Nobuhisa; Ito, Yoichi M.; Iwasaki, Sumio; Nagao, Miki; Kawamura, Hideki; Kanai, Shinichiro; Nukui, Yoko; Tokuda, Koichi; Miyara, Takayuki; Igari, Hidetoshi; Yamada, Koichi; Chikumi, Hiroki; Sano, Chiaki; Koike, Ryuji; Yagi, Tetsuya; Murakami, Nobuo; Japan Infection Prevention, Control Conference for National, Public University Hospitals
- Abstract
<bold>Background: </bold>In a previous retrospective observational study, a 3-day regimen of oseltamivir as post-exposure prophylaxis (PEP) for preventing transmission of influenza in wards was shown to be comparable to 7- to 10-day regimens provided index cases were immediately separated from close contacts. In order to confirm the efficacy of a 3-day regimen, we started to conduct a prospective, multi-center, single-arm trial.<bold>Methods: </bold>This study is a prospective, multi-center, single-arm study designed by the Sectional Meeting of Clinical Study, Japan Infection Prevention and Control Conference for National and Public University Hospitals. Index patients with influenza are prescribed a neuraminidase inhibitor and are discharged immediately or transferred to isolation rooms. The close contacts are given oseltamivir as 75 mg capsules once daily for adults or 2 mg/kg (maximum of 75 mg) once daily for children for 3 days as PEP. All close contacts are monitored for development of influenza for 7 days after starting PEP.<bold>Discussion: </bold>A 3-day regimen of oseltamivir as PEP has advantages over 7- to 10-day regimens in terms of costs, medication adherence and adverse effects. Trial registration The Institutional Review Board of Hokkaido University Hospital for Clinical Research, 015-0518, registered on November 11, 2016. UMIN Clinical Trials Registry, UMIN000024458, disclosed on October 31, 2016. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027881 . Japan Registry of Clinical Trials, jRCTs011180015, disclosed on March 14, 2019. https://jrct.niph.go.jp/latest-detail/jRCTs011180015.
- Subjects
JAPAN; HOSPITAL wards; RESEARCH protocols; MEDICAL research; INFLUENZA; OSELTAMIVIR
- Publication
BMC Infectious Diseases, 2021, Vol 21, Issue 1, p1
- ISSN
1471-2334
- Publication type
journal article
- DOI
10.1186/s12879-021-06602-w