Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

NCT01353768 | Completed

• 1 other identifier: 115008
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infections, Respiratory Tract

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Mortality

  Number of patients who died

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

Secondary Outcomes (9)

• Other anti-influenza therapies

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

• Chest X-ray abnormalities

  within 1-2 days of hospital admission or symptom onset

• 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

Study Arms (1)

No treatment

zanamivir aqueous solution administered previously as part of the Compassionate Use Program

Other: retrospective chart review

Interventions

retrospective chart review OTHER

retrospective chart review

No treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related 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.

MeSH Terms

Conditions

Respiratory Tract Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: May 16, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share