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Completed

NCT Number: NCT01353768

Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

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.

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Key information

Conditions

Infections, Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrospective Chart Review

Other

retrospective chart review

Primary outcomes

  1. Mortality

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients who died

Secondary outcomes

  1. Other anti-influenza therapies

    Time frame: for duration of influenza-related hospitalization, an expected average of 5 weeks

    Number of patients who received other anti-influenza therapies

  2. Chest X-ray abnormalities

    Time frame: within 1-2 days of hospital admission or symptom onset

    Number of patients with abnormal findings

  3. Resistance to zanamivir

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients with documentation of resistance

  4. Other infections

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients with diagnosis of other infections

  5. Complications of influenza

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients with complications of influenza

  6. Ventilation/Oxygenation

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients requiring ventilation support or supplemental oxygen

  7. Concomitant Medications

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients receiving antibiotic/, antifungal/, orticosteroids, or inotropic medications

  8. Treatment emergent events

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients experiencing a treatment emergent event

  9. Hemodialysis/Renal Replacement Therapy

    Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks

    Number of patients receiving hemodialysis or renal replacement therapy

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2011
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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