A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza
NCT ID: NCT01052961
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
157 participants
INTERVENTIONAL
2010-01-31
2012-06-30
Brief Summary
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The investigators plan to investigate the impact of higher-dose oseltamivir (150 mg b.d.) treatment on viral clearance and clinical recovery in adult patients hospitalized for severe influenza. Such information may lead to optimization of the management strategy used for these patients.
Detailed Description
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* Patients who received intervention (oseltamivir 150 mg b.d. for 5 days) will be compared to those in the non-intervention arm (patients may receive oseltamivir treatment at 75 mg b.d. for 5 days, decided by their managing physicians) in the two respective study sites. Viral load changes and viral clearance will be compared. Clinical progress and time to symptom recovery will be reported. The protocol will be crossed-over to the other site at a defined time frame.
* oseltamivir 150 mg b.d. has been shown to be safe and well-tolerated in earlier clinical trials
* higher-dose treatment has been suggested by health authorities (e.g. WHO) to treat severe influenza infection/pneumonia.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-intervention arm
patients may receive oseltamivir 75 mg bd for 5 days, decided by the managing physicians
No interventions assigned to this group
oseltamivir, higher dose
oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset
Oseltamivir
oseltamivir 150 mg bd for 5 days
Interventions
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Oseltamivir
oseltamivir 150 mg bd for 5 days
Eligibility Criteria
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Inclusion Criteria
* presented within 96 hours from symptom onset
* age \>/= 18 years
Exclusion Criteria
* suspected avian influenza
* patients who have received antivirals against influenza prior to admission
* suspected or confirmed oseltamivir resistance
* pre-existing renal impairment, with creatinine clearance \<40 ml/min
* pre-existing hepatic failure
* participation in a clinical study involving experimental medication in the past 4 weeks
* pregnant women, or who are attempting to become pregnant, or who are breast feeding.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Chinese University of Hong Kong
OTHER
Responsible Party
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Nelson Lee
Professor
Principal Investigators
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Nelson LS Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hksar, Hong Kong
Countries
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References
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Lee N, Chan PK, Hui DS, Rainer TH, Wong E, Choi KW, Lui GC, Wong BC, Wong RY, Lam WY, Chu IM, Lai RW, Cockram CS, Sung JJ. Viral loads and duration of viral shedding in adult patients hospitalized with influenza. J Infect Dis. 2009 Aug 15;200(4):492-500. doi: 10.1086/600383.
Lee N, Cockram CS, Chan PK, Hui DS, Choi KW, Sung JJ. Antiviral treatment for patients hospitalized with severe influenza infection may affect clinical outcomes. Clin Infect Dis. 2008 Apr 15;46(8):1323-4. doi: 10.1086/533477. No abstract available.
Lee N, Wong CK, Chan PK, Lun SW, Lui G, Wong B, Hui DS, Lam CW, Cockram CS, Choi KW, Yeung AC, Tang JW, Sung JJ. Hypercytokinemia and hyperactivation of phospho-p38 mitogen-activated protein kinase in severe human influenza A virus infection. Clin Infect Dis. 2007 Sep 15;45(6):723-31. doi: 10.1086/520981. Epub 2007 Aug 8.
Lee N, Chan PK, Choi KW, Lui G, Wong B, Cockram CS, Hui DS, Lai R, Tang JW, Sung JJ. Factors associated with early hospital discharge of adult influenza patients. Antivir Ther. 2007;12(4):501-8.
Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, Singh S, Kinnersley N, Ward P, Mills RG. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA. 2000 Feb 23;283(8):1016-24. doi: 10.1001/jama.283.8.1016.
Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, Rode A, Kinnersley N, Ward P. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000 May 27;355(9218):1845-50. doi: 10.1016/s0140-6736(00)02288-1.
World Health Organization. Clinical management of human infection with pandemic (H1N1) 2009: revised guidance. Available at: http://www.who.int/csr/resources/publications/swineflu/clinical_management_h1n1.pdf. Last accessed on 1st Dec, 2009
Lee N, Hui DS, Zuo Z, Ngai KL, Lui GC, Wo SK, Tam WW, Chan MC, Wong BC, Wong RY, Choi KW, Sin WW, Lee EL, Tomlinson B, Hayden FG, Chan PK. A prospective intervention study on higher-dose oseltamivir treatment in adults hospitalized with influenza a and B infections. Clin Infect Dis. 2013 Dec;57(11):1511-9. doi: 10.1093/cid/cit597. Epub 2013 Sep 17.
Other Identifiers
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CUHK 7010015, MV22926
Identifier Type: -
Identifier Source: org_study_id