Adjuvant Steroids in Adults with Pandemic influenza

Phase 3

• Conditions: Influenza; Respiratory; Influenza, virus not identified

• Registration Number: ISRCTN72331452
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25716702 protocol 2017 Other publications in https://doi.org/10.1186/s13063-017-2290-z Simulated activation of study (added 16/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-11
• Last Update Posted: 28 November 2022
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

This trial will be activated in the event of a pandemic. Trial activation will be decided by the NIHR in close discussion with the Trial Steering Committee, the Chief Investigators of the eight NIHR Pandemic Portfolio studies and the Department of Health. The following inclusion criteria will apply when the trial is activated:
During an influenza pandemic, patients are eligible for the entry into the trial if they:
1. Are aged = 16 years
2. Have been admitted to hospital within the previous 24 hours with a clinical diagnosis of an influenza-like illness
3. Have given consent

Exclusion Criteria

Patients are not eligible for the study if ANY of the following apply at the time of admission to hospital:
1. Known to be taking oral or intravenous corticosteroid treatment
2. Require treatment with oral or intravenous corticosteroids upon admission to hospital as standard treatment for comorbid illness.
3. Known to be on insulin or oral medication for the treatment of diabetes mellitus
4. Known contra-indication to dexamethasone or any of the excipients

Study & Design

• Study Type: Interventional
• Study Design: Not specified