Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01353768
First received: April 21, 2011
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Infections, Respiratory Tract
Other: retrospective chart review

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mortality [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients who died


Secondary Outcome Measures:
  • Other anti-influenza therapies [ Time Frame: for duration of influenza-related hospitalization, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients who received other anti-influenza therapies

  • Chest X-ray abnormalities [ Time Frame: within 1-2 days of hospital admission or symptom onset ] [ Designated as safety issue: No ]
    Number of patients with abnormal findings

  • Resistance to zanamivir [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients with documentation of resistance

  • Other infections [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients with diagnosis of other infections

  • Complications of influenza [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients with complications of influenza

  • Ventilation/Oxygenation [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients requiring ventilation support or supplemental oxygen

  • Concomitant Medications [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients receiving antibiotic/, antifungal/, orticosteroids, or inotropic medications

  • Treatment emergent events [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients experiencing a treatment emergent event

  • Hemodialysis/Renal Replacement Therapy [ Time Frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Number of patients receiving hemodialysis or renal replacement therapy


Enrollment: 113
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
zanamivir aqueous solution administered previously as part of the Compassionate Use Program
Other: retrospective chart review
retrospective chart review

Detailed Description:

This is an observational, retrospective, multi-centre, cohort data collection study.

The CUP retrospective review study has been designed to collect safety and clinical outcome data from pediatric and pregnant patients (collectively referred to as the "Tier 1" cohort) treated globally within the CUP during the 2009/2010 pandemic (from May 2009) through 31 January 2011. The study will also attempt to collect data from other adult patients (referred to as the "Tier 2" cohort) who were treated at sites identified as having Tier 1 patients.

The treating physician at each site will receive a letter from the GSK medical director inviting him/her to participate in the retrospective chart review study. Physicians (or their delegates) who agree to participate will receive study-related documentation [including the protocol and case report form (CRF)] to orient the site to the study details and CRF. For the purposes of this study, the term "site" generally refers to a hospital where in-patient treatment was provided.

The retrospective chart review will be monitored via remote visits by telephone. The interviewer will be a Kendle associate assigned to the study who will not have direct access to the patient's source documents or medical records during conduct of the study. The physician/delegate will review the patient's chart and record data on a paper CRF. The CRF will be in the English language. Site personnel will mail completed CRFs to Kendle. Kendle will review the CRF for data quality, and conduct a remote monitoring visit via telephone to address any data queries, if required. No visits to participating sites are planned.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

350 patients previously treated with zanamivir aqueous solution as part of the CUP, at an estimated 100 sites in over 15 countries are targeted for participation. Medical information on safety and clinical outcomes from Tier 1 and Tier 2 patients will be collected within this retrospective chart review study.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353768

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01353768     History of Changes
Other Study ID Numbers: 115008
Study First Received: April 21, 2011
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Influenza

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Pharmaceutical Solutions
Zanamivir
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014