A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection (208165)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48211
• EU PAS number:
  EUPAS37605
• Study ID:
  48211
• Official title and acronym:
  A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection (208165)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom
• Study description:
  The study aims to gain an understanding of the clinical management of complicated influenza in ICUs in Europe and to investigate the clinical effectiveness of IV Zanamivir in the treatment of patients with complicated influenza in this setting.
• Study status:
  Ongoing

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 25/07/2019

Actual: 25/07/2020

Study start date

Planned: 26/10/2020

Actual: 03/11/2020

Date of final study report

Planned: 30/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-208165-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable