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Title: | Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: Double blind randomised controlled trial |
Authors: | Endang Rahayu Sedyaningsih Moh Suhud Malik Vivi Setiawaty Trihono Trihono Erlina Burhan Tjandra Yoga Aditama Prijanti Z. Soepandi Lia G. Partakusuma Agung P. Sutiyoso Ika Priatni Hadi Jusuf Emmy Hermiyanti Pranggono Arto Yuwono Soeroto Djatnika Setiabudi Dadang Hudaya Somasetia Sri Sudarwati Tini T. Maskoen Yovita Hartantri Ida Parwati Sardikin Giriputro Dewi Murniati Sondang Maryutka Sirait Tony Soetanto Sri Sulastri Rismali Agus Adria Rusli Sila Wiweka Steve Wignall Kevin Baird Iko Safika Chariya Sangsajja Weerawat Manosuthi Patama Sutha Chareon Chuchottaworn Piamlarp Sansayunh Kittima Bangpattanasiri Walter R.J. Taylor Kasia Stepniewska Caroline Fukuda Niklas Lindegardh Nicholas White Nick Day Tawee Chotpitayasunondh Piyarat Suntarattiwong Umaporn Chantbuddhiwet Supichaya Netsawang Kulkanya Chokephaibulkit Nirun Vanprapar Wasana Prasitsuebsai Orasri Wittawatmongkol Thanomsak Anekthananon Winai Ratanasuwan Yong Rongrungruang Pilaipan Puthavathana Paul A. Tambyah Yee Sin Leo Dale Fisher Louis Chai Lawrence Lee Raymond Lin Ngo Ngoc Quang Minh Truong Huu Khanh Le Phan Kim Thoa Le Anh Tuan Tran Thi My Dung Lam Thi Thuy Ha Le Minh Qui Le Quoc Thinh Nguyen Ngoc Tu Anh Tran Anh Tuan Trinh Hong Nhien Bui Pham Phuong Phan Tu Qui Tieu Chau Thy Bui Xuan Vu Le Binh Bao Tinh Dang Thi Thanh Vo Phuong Khanh Do Chau Viet Tran Thi Thuy Vo Quoc Bao Le Nguyen Nhat Trung Ho Thi Kim Thoa Tran Thi Ngoc Anh Tran Thi Thu Loan Tran Quynh Huong Nguyen Thi Hanh Le Ho Lu Viet Ha Manh Tuan Nguyen Thi Thanh Ha Nguyen Van Vinh Chau Nguyen Thanh Truong Le Thi Thu Thao Nguyen Thanh Phong Pham Tran Dieu Hien Pham Thi Hai Men Cao Thi Tam Tran Vinh Diet Nguyen Van Hao Badan Penelitian Dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia Persahabatan Hospital Rumah Sakit Hasan Sadikan Bandung Sulianto Saroso Hospital Jakarta Eijkman Oxford Clinical Research Unit Bamrasnaradura Infectious Disease Institute Chest Disease Institute Nonthaburi Mahidol Oxford Research Unit Bangkok Queen Sirikit National Institute of Child Health Mahidol University National University Hospital, Singapore Children's Hospital 1 Children's Hospital 2 UCL National Hospital for Tropical Diseases |
Keywords: | Medicine |
Issue Date: | 8-Jun-2013 |
Citation: | BMJ (Online). Vol.346, No.7911 (2013) |
Abstract: | Objective: To investigate the validity of recommendations in treatment guidelines to use higher than approved doses of oseltamivir in patients with severe influenza. Design: Double blind randomised trial. Setting: Thirteen hospitals in Indonesia, Singapore, Thailand, and Vietnam. Participants: Patients aged ≥1 year admitted to hospital with confirmed severe influenza. Interventions: Oral oseltamivir at double dose (150 mg twice a day/paediatric equivalent) versus standard dose (75 mg twice a day/paediatric equivalent). Main outcome measure: Viral status according to reverse transcriptase polymerase chain reaction (RT-PCR) for influenza RNA in nasal and throat swabs on day five. Results: Of 326 patients (including 246 (75.5%) children aged <15), 165 and 161 were randomised to double or standard dose oseltamivir, respectively. Of these, 260 (79.8%) were infected with influenza virus A (133 (40.8%) with A/H3N2, 72 (22.1%) with A/H1N1-pdm09, 38 (11.7%) with seasonal A/H1N1, 17 (5.2%) with A/H5N1) and 53 (16.2%) with influenza virus B. A further 3.9% (13) were false positive by rapid antigen test (negative by RT-PCR and no rise in convalescent haemagglutination inhibition titers). Similar proportions of patients were negative for RT-PCR on day five of treatment: 115/159 (72.3%, 95% confidence interval 64.9% to 78.7%) double dose recipients versus 105/154 (68.2%, 60.5% to 75.0%) standard dose recipients; difference 4.2% (-5.9 to 14.2); P=0.42. No differences were found in clearance of virus in subgroup analyses by virus type/subtype, age, and duration of illness before randomisation. Mortality was similar: 12/165 (7.3%, 4.2% to 12.3%) in double dose recipients versus 9/161 (5.6%, 3.0% to 10.3%) in standard dose recipients. No differences were found between double and standard dose arms in median days on supplemental oxygen (3 (interquartile range 2-5) v 3.5 (2-7)), in intensive care (4.5 (3-6) v 5 (2-11), and on mechanical ventilation (2.5 (1-16) v 8 (1-16)), respectively. No important differences in tolerability were found. Conclusions: There were no virological or clinical advantages with double dose oseltamivir compared with standard dose in patients with severe influenza admitted to hospital. Registration: Clinical Trials NCT00298233. |
URI: | https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84878821350&origin=inward http://repository.li.mahidol.ac.th/dspace/handle/123456789/32300 |
ISSN: | 17561833 |
Appears in Collections: | Scopus 2011-2015 |
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