Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Respiratory Tract
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Actual): 113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment; zanamivir aqueous solution administered previously as part of the Compassionate Use Program	Other: retrospective chart review; retrospective chart review

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: May 12, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 115008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 115008
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register