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
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 cont...
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| Language: | English |
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BMC
2021-08-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | https://doi.org/10.1186/s12879-021-06602-w |
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| author | 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 |
| author_facet | 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 |
| author_sort | Nobuhisa Ishiguro |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-22T04:59:47Z |
| format | Article |
| id | doaj.art-48bd89a96a3c48bda55d8d2b1b4764b7 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-22T04:59:47Z |
| publishDate | 2021-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-48bd89a96a3c48bda55d8d2b1b4764b72022-12-21T18:38:17ZengBMCBMC Infectious Diseases1471-23342021-08-012111510.1186/s12879-021-06602-wThree-day regimen of oseltamivir for post-exposure prophylaxis of influenza in hospital wards: a study protocol for a prospective, multi-center, single-arm trialNobuhisa Ishiguro0Yoichi M. Ito1Sumio Iwasaki2Miki Nagao3Hideki Kawamura4Shinichiro Kanai5Yoko Nukui6Koichi Tokuda7Takayuki Miyara8Hidetoshi Igari9Koichi Yamada10Hiroki Chikumi11Chiaki Sano12Ryuji Koike13Tetsuya Yagi14Nobuo Murakami15Japan Infection Prevention, Control Conference for National, Public University HospitalsDivision of Infection Control, Hokkaido University HospitalDepartment of Statistical Data Science, The Institute of Statistical MathematicsDivision of Infection Control, Hokkaido University HospitalDepartment of Infection Control and Prevention, Kyoto University HospitalDepartment of Infection Control and Prevention, Division of Medical and Environmental Safety, Kagoshima University HospitalDivision of Infection Control, Shinshu University HospitalDepartment of Infection Control and Prevention, Medical Hospital, Tokyo Medical and Dental UniversityDepartment of Infection Control and Laboratory Diagnostics, Tohoku University Graduate School of MedicineInfection Control Team, Kobe University HospitalDivision of Infection Control, Chiba University HospitalDepartment of Infection Control Science, Graduate School of Medicine, Osaka City UniversityCenter for Infectious Diseases, Tottori University HospitalDivision of Infection Control, Shimane University HospitalDepartment of Infection Control and Prevention, Medical Hospital, Tokyo Medical and Dental UniversityDepartment of Infectious Diseases, Nagoya University HospitalCenter for Regional Medicine, Gifu University School of MedicineAbstract 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/jRCTs011180015https://doi.org/10.1186/s12879-021-06602-wOseltamivirPost-exposure prophylaxisInfluenzaHospital wards |
| spellingShingle | 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 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 Oseltamivir Post-exposure prophylaxis Influenza Hospital wards |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Oseltamivir Post-exposure prophylaxis Influenza Hospital wards |
| url | https://doi.org/10.1186/s12879-021-06602-w |
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