MedDataX Logo

Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

NCT ID: NCT01353768

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections, Respiratory Tract

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No treatment

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

retrospective chart review

Intervention Type OTHER

retrospective chart review

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

retrospective chart review

retrospective chart review

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

115008

Identifier Type: -

Identifier Source: org_study_id