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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/32300
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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