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Peramivir Treatment Response in Adults Hospitalized for Influenza-associated Lower Respiratory Tract Infections

NCT ID: NCT02665351

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-03-31

Brief Summary

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Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous therapy lies mainly with patients hospitalized with complicated diseases, such data are limited because of feasibility and ethical considerations for placebo-controlled studies.

In this study, the investigators aimed to examine more specifically treatment effects of peramivir in adults hospitalized with influenza-associated lower respiratory tract complications (LRTC). Such findings may have important implications on clinical management.

Detailed Description

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The primary objective was to assess the virologic response of peramivir in influenza-associated lower respiratory tract complications (LRTC). The secondary objective was to assess safety and tolerability. Adults confirmed with influenza by polymerase chain reaction (PCR) and/or immunofluorescence assays during the seasonal peaks of 2011-2014 were assessed for eligibility. Consented individuals were randomized to receive either peramivir 600mg every 24 hourly or 300mg every 12 hourly for 5 days. In subjects not achieving clinical resolution by day 5, the same regimen could be continued until day 10 (virologic results unknown to clinicians).Renal-dosage adjustment, if required, was performed according to protocol.

The study's primary endpoint was change in influenza RNA load over time. The secondary endpoints were viral shedding indicated by culture and RNA negativity at day 5, and drug tolerability.

Additionally, a priori comparisons of these endpoints with historical controls treated with standard courses of oral oseltamivir (75mg bid for 5 days) in the same clinical settings were performed.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peramivir 300mg Q12H

Peramivir 300 mg, administered intravenously, twice daily (every 12 hours)

Group Type ACTIVE_COMPARATOR

Peramivir

Intervention Type DRUG

The two regimens of Peramivir were compared

Peramivir 600mg Q24H

Peramivir 600 mg, administered intravenously, once daily (every 24 hrs)

Group Type ACTIVE_COMPARATOR

Peramivir

Intervention Type DRUG

The two regimens of Peramivir were compared

Interventions

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Peramivir

The two regimens of Peramivir were compared

Intervention Type DRUG

Other Intervention Names

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intravenous neuraminidase inhibitor

Eligibility Criteria

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Inclusion Criteria

* symptoms/signs of influenza, and
* confirmation of lower respiratory tract infection (e.g. radiographic pneumonia, dyspnea caused by acute exacerbation of underlying airway diseases, bronchitis, or combinations).

Exclusion Criteria

* late presentation \>1 week from onset,
* hemodynamic instability,
* hepatic/renal failure,
* dialysis,
* immunosuppression (e.g. transplant, chemotherapy), and
* pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Prof David Shu Cheong Hui

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nelson Lee

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Other Identifiers

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Peramivir in adult influenza_1

Identifier Type: -

Identifier Source: org_study_id