Browsing by Author "Le Phan Kim Thoa"

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    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
    (2013-06-08) 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
    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.