A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza

NCT01052961 | Completed Phase 4

• 1 other identifier: CUHK 7010015, MV22926
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients hospitalized with influenza have higher viral loads and more severe illnesses. Thus more aggressive treatment approaches (e.g. higher dose oseltamivir) have been suggested to treat patients suffering from severe influenza infection. 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.

Conditions

Influenza; Respiratory Tract Infections

Keywords

severe influenza; hospitalized adults; oseltamivir treatment

Outcome Measures

Primary Outcomes (1)

• rate of influenza virus load decline and viral RNA negativity upon receiving 5 days of study treatment

  during and upon completion of the 5-day study treatment

Secondary Outcomes (1)

• time to clinical recovery (including symptoms, vital signs, hospital discharge)

  during and upon completion of the 5-day study treatment

Study Arms (2)

Non-intervention arm

NO INTERVENTION

patients may receive oseltamivir 75 mg bd for 5 days, decided by the managing physicians

oseltamivir, higher dose

ACTIVE COMPARATOR

oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset

Drug: Oseltamivir

Interventions

Oseltamivir DRUG

oseltamivir 150 mg bd for 5 days

oseltamivir, higher dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed influenza A (H1N1, H3N2) or B infection by IFA or RT-PCR, with a compatible clinical illness
• presented within 96 hours from symptom onset
• age \>/= 18 years

You may not qualify if:

• lack of consent
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hksar, Hong Kong

Location

Related Publications (8)

• 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.

  PMID: 19591575 BACKGROUND

• 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.

  PMID: 18444878 BACKGROUND

• 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.

  PMID: 17712756 BACKGROUND

• 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.

  PMID: 17668558 BACKGROUND

• 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.

  PMID: 10697061 BACKGROUND

• 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.

  PMID: 10866439 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24046309 DERIVED

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nelson LS Lee, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

HK (1)