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

• Published in: BMC infectious diseases 2021-08, Vol.21 (1), p.887-887, Article 887
• Main 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
• Format: Article
• Language: English
• Subjects: Adult; Antiviral Agents - therapeutic use; Antiviral drugs; Child; Clinical trials; Creatinine; Disease prevention; Drug therapy; Exo-a-sialidase; Exposure; Fever; Hospital wards; Hospitals; Humans; Immunization; Infections; Influenza; Influenza, Human - drug therapy; Influenza, Human - prevention & control; Oseltamivir; Oseltamivir - therapeutic use; Oseltamivir phosphate; Participation; Patients; Post-Exposure Prophylaxis; Prophylaxis; Prospective Studies; Quality control; Study Protocol
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-021-06602-w

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. 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. 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.