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

Nobuhisa Ishiguro; Yoichi M Ito; Sumio Iwasaki; Miki Nagao; Hideki Kawamura; Shinichiro Kanai; Yoko Nukui; Koichi Tokuda; Takayuki Miyara; Hidetoshi Igari; Koichi Yamada; Hiroki Chikumi; Chiaki Sano; Ryuji Koike; Tetsuya Yagi; Nobuo Murakami; Japan Infection Prevention, Control Conference for National, Public University Hospitals

doi:10.1186/s12879-021-06602-w

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 Infect Dis. 2021 Aug 30;21(1):887. doi: 10.1186/s12879-021-06602-w.

Authors

Nobuhisa Ishiguro¹, Yoichi M Ito², Sumio Iwasaki³, Miki Nagao⁴, Hideki Kawamura⁵, Shinichiro Kanai⁶, Yoko Nukui⁷, Koichi Tokuda⁸, Takayuki Miyara⁹, Hidetoshi Igari¹⁰, Koichi Yamada¹¹, Hiroki Chikumi¹², Chiaki Sano¹³, Ryuji Koike⁷, Tetsuya Yagi¹⁴, Nobuo Murakami¹⁵; Japan Infection Prevention, Control Conference for National, Public University Hospitals

Affiliations

¹ Division of Infection Control, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido, 060-8648, Japan. nisgr@mrj.biglobe.ne.jp.
² Department of Statistical Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan.
³ Division of Infection Control, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido, 060-8648, Japan.
⁴ Department of Infection Control and Prevention, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto, 606-8507, Japan.
⁵ Department of Infection Control and Prevention, Division of Medical and Environmental Safety, Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima, Kagoshima, 890-8544, Japan.
⁶ Division of Infection Control, Shinshu University Hospital, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
⁷ Department of Infection Control and Prevention, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
⁸ Department of Infection Control and Laboratory Diagnostics, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
⁹ Infection Control Team, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
¹⁰ Division of Infection Control, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.
¹¹ Department of Infection Control Science, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, Osaka, 545-8585, Japan.
¹² Center for Infectious Diseases, Tottori University Hospital, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan.
¹³ Division of Infection Control, Shimane University Hospital, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.
¹⁴ Department of Infectious Diseases, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Nagoya, 466-8560, Japan.
¹⁵ Center for Regional Medicine, Gifu University School of Medicine, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Keywords: Hospital wards; Influenza; Oseltamivir; Post-exposure prophylaxis.

Publication types

Clinical Trial
Multicenter Study

MeSH terms

Adult
Antiviral Agents / therapeutic use
Child
Hospitals
Humans
Influenza, Human* / drug therapy
Influenza, Human* / prevention & control
Oseltamivir* / therapeutic use
Post-Exposure Prophylaxis
Prospective Studies

Substances

Antiviral Agents
Oseltamivir