Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

Infections, Respiratory Tract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353768
• Other study ID #: 115008
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: November 21, 2016
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infections, Respiratory Tract
• Respiratory Tract Infections

Intervention

Other:
• retrospective chart review
retrospective chart review

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of patients who died	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	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	No
Secondary	Chest X-ray abnormalities	Number of patients with abnormal findings	within 1-2 days of hospital admission or symptom onset	No
Secondary	Resistance to zanamivir	Number of patients with documentation of resistance	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	Other infections	Number of patients with diagnosis of other infections	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	Complications of influenza	Number of patients with complications of influenza	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	Ventilation/Oxygenation	Number of patients requiring ventilation support or supplemental oxygen	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	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	No
Secondary	Treatment emergent events	Number of patients experiencing a treatment emergent event	for duration of influenza-related hospitalization, an expected average duration of 5 weeks	No
Secondary	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	No

External Links

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