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

BMC Infectious Diseases

Hiroki Chikumi¹  Nobuo Murakami²  Koichi Yamada³  Koichi Tokuda⁴  Hideki Kawamura⁵  Miki Nagao⁶  Yoko Nukui⁷  Ryuji Koike⁷  Tetsuya Yagi⁸  Yoichi M. Ito⁹  Hidetoshi Igari^1,10  Sumio Iwasaki^1,11  Nobuhisa Ishiguro^1,11  Chiaki Sano^1,12  Shinichiro Kanai^1,13  Takayuki Miyara^1,14 

[1] Center for Infectious Diseases, Tottori University Hospital, 36-1 Nishi-cho, 683-8504, Yonago, Tottori, Japan;Center for Regional Medicine, Gifu University School of Medicine, 1-1 Yanagido, 501-1194, Gifu, Gifu, Japan;Department of Infection Control Science, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, 545-8585, Osaka, Osaka, Japan;Department of Infection Control and Laboratory Diagnostics, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, 980-8575, Sendai, Miyagi, Japan;Department of Infection Control and Prevention, Division of Medical and Environmental Safety, Kagoshima University Hospital, 8-35-1 Sakuragaoka, 890-8544, Kagoshima, Kagoshima, Japan;Department of Infection Control and Prevention, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, 606-8507, Kyoto, Kyoto, Japan;Department of Infection Control and Prevention, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, 113-8510, Tokyo, Japan;Department of Infectious Diseases, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, 466-8560, Nagoya, Nagoya, Japan;Department of Statistical Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, 190-8562, Tachikawa, Tokyo, Japan;Division of Infection Control, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, 260-8677, Chiba, Chiba, Japan;Division of Infection Control, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-Ku, 060-8648, Sapporo, Hokkaido, Japan;Division of Infection Control, Shimane University Hospital, 89-1 Enya-cho, 693-8501, Izumo, Shimane, Japan;Division of Infection Control, Shinshu University Hospital, 3-1-1 Asahi, 390-8621, Matsumoto, Nagano, Japan;Infection Control Team, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, 650-0017, Kobe, Hyogo, Japan;

关键词: Oseltamivir;    Post-exposure prophylaxis;    Influenza;    Hospital wards;   

DOI  :  10.1186/s12879-021-06602-w

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsThis 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.DiscussionA 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

【 授权许可】

CC BY