NCT02665351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

3.1 years

First QC Date

January 22, 2016

Last Update Submit

January 28, 2016

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • change in influenza RNA load

    5-10 days

    5 days

Secondary Outcomes (1)

  • viral shedding indicated by PCR and culture negativity

    5 days

Study Arms (2)

Peramivir 300mg Q12H

ACTIVE COMPARATOR

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

Drug: Peramivir

Peramivir 600mg Q24H

ACTIVE COMPARATOR

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

Drug: Peramivir

Interventions

PeramivirDRUG

The two regimens of Peramivir were compared

Also known as: intravenous neuraminidase inhibitor
Peramivir 300mg Q12HPeramivir 600mg Q24H

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

peramivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Nelson Lee

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 29, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)