Last updated: 11/07/2018 08:29:21

Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

Request patient level data
GSK study ID
115008
See study documents
Clinicaltrials.gov ID
NCT01353768
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients treated with IV zanamivir in the Relenza Compassionate Use Program
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mortality

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

Secondary outcomes:

Other anti-influenza therapies

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

Chest X-ray abnormalities

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

Resistance to zanamivir

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

Other infections

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

Complications of influenza

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

Ventilation/Oxygenation

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

Concomitant Medications

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

Treatment emergent events

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

Hemodialysis/Renal Replacement Therapy

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

Interventions:
Other: retrospective chart review
Enrollment:
113
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Respiratory Tract
Product
zanamivir
Collaborators
Not applicable
Study date(s)
July 2011 to January 2012
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • 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.
  • 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.
Inclusion and exclusion criteria
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.

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-27-01

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website