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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborator: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.