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
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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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