Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients Treated With IV Zanamivir in the Relenza Compassionate Use Program

Conditions
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Infections, Respiratory Tract

Intervention / Treatment
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* Other: retrospective chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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: Adult patients that received zanamivir aqueous solution at non-Tier 1 sites. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>zanamivir aqueous solution administered previously as part of the Compassionate Use Program | Other: retrospective chart review<br>* retrospective chart review<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of patients who died | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other anti-influenza therapies | Number of patients who received other anti-influenza therapies | for duration of influenza-related hospitalization, an expected average of 5 weeks | 
| Chest X-ray abnormalities | Number of patients with abnormal findings | within 1-2 days of hospital admission or symptom onset | 
| Resistance to zanamivir | Number of patients with documentation of resistance | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Other infections | Number of patients with diagnosis of other infections | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Complications of influenza | Number of patients with complications of influenza | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Ventilation/Oxygenation | Number of patients requiring ventilation support or supplemental oxygen | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Concomitant Medications | Number of patients receiving antibiotic/, antifungal/, orticosteroids, or inotropic medications | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Treatment emergent events | Number of patients experiencing a treatment emergent event | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 
| Hemodialysis/Renal Replacement Therapy | Number of patients receiving hemodialysis or renal replacement therapy | for duration of influenza-related hospitalization, an expected average duration of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza