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

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators plan to study the impact of higher-dose oseltamivir (150 mg b.d.) treatment on rate of viral load decline and RNA negativity (in nasal and throat swabs, assessed by quantitative RT-PCR assay) and time to clinical recovery in adult patients hospitalized for severe influenza. 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.

Official Title
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Initiating Oseltamivir in Adults Hospitalized With Influenza -- a Study on the Impact of Virological Clearance and Clinical Recovery for Higher-dose Treatment Started Within 96 Hours

Conditions
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Influenza, Respiratory Tract Infections

Intervention / Treatment
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* Drug: Oseltamivir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-intervention arm<br>patients may receive oseltamivir 75 mg bd for 5 days, decided by the managing physicians | |
| Active Comparator: oseltamivir, higher dose<br>oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset | Drug: Oseltamivir<br>* oseltamivir 150 mg bd for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to clinical recovery (including symptoms, vital signs, hospital discharge) |  | during and upon completion of the 5-day study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe influenza, hospitalized adults, oseltamivir treatment