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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052961

Enrollment

157

Registered

2010-01-21

Start date

2010-01-31

Completion date

2012-06-30

Last updated

2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Respiratory Tract Infections

Keywords

severe influenza, hospitalized adults, oseltamivir treatment

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.

Detailed description

* 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.

Interventions

DRUGOseltamivir

oseltamivir 150 mg bd for 5 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026