Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients Treated With IV Zanamivir in the Relenza Compassionate Use Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mortality
时间窗: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Number of patients who died
次要结局
- Chest X-ray abnormalities(within 1-2 days of hospital admission or symptom onset)
- Other anti-influenza therapies(for duration of influenza-related hospitalization, an expected average of 5 weeks)
- Hemodialysis/Renal Replacement Therapy(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Resistance to zanamivir(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Other infections(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Complications of influenza(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Ventilation/Oxygenation(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Concomitant Medications(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)
- Treatment emergent events(for duration of influenza-related hospitalization, an expected average duration of 5 weeks)