A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza
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|ClinicalTrials.gov Identifier: NCT01052961|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : July 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza Respiratory Tract Infections||Drug: Oseltamivir||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
No Intervention: Non-intervention arm
patients may receive oseltamivir 75 mg bd for 5 days, decided by the managing physicians
Active Comparator: oseltamivir, higher dose
oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset
oseltamivir 150 mg bd for 5 days
- rate of influenza virus load decline and viral RNA negativity upon receiving 5 days of study treatment [ Time Frame: during and upon completion of the 5-day study treatment ]
- time to clinical recovery (including symptoms, vital signs, hospital discharge) [ Time Frame: during and upon completion of the 5-day study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052961
|The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital|
|Hong Kong, Hksar, Hong Kong|
|Principal Investigator:||Nelson LS Lee, MD||Chinese University of Hong Kong|