Last updated: 11/07/2018 08:29:21

Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

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GSK study ID
115008
See study documents
Clinicaltrials.gov ID
NCT01353768
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients treated with IV zanamivir in the Relenza Compassionate Use Program
Trial description: GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. The retrospective chart review is intended to gain a better understanding of the safety profile of investigational zanamivir and of clinical outcomes in the large number of patients treated outside of a clinical trial setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mortality

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Secondary outcomes:

Other anti-influenza therapies

Timeframe: for duration of influenza-related hospitalization, an expected average of 5 weeks

Chest X-ray abnormalities

Timeframe: within 1-2 days of hospital admission or symptom onset

Resistance to zanamivir

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Other infections

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Complications of influenza

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Ventilation/Oxygenation

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Concomitant Medications

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Treatment emergent events

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Hemodialysis/Renal Replacement Therapy

Timeframe: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

Interventions:
  • Other: retrospective chart review
    • Enrollment:
    113
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Respiratory Tract
    Product
    zanamivir
    Collaborators
    Not applicable
    Study date(s)
    July 2011 to January 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • 1. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011 (Tier 1 cohort).
    • 2. Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient.
    • 1. Adult patients that received zanamivir aqueous solution at non-Tier 1 sites.
    • 2. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011 (Tier 1 cohort). 2. Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient.
    Exclusion criteria:
    • 1. Adult patients that received zanamivir aqueous solution at non-Tier 1 sites. 2. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-27-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

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    Additional information
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