Actively Recruiting
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Led by Instituto de Investigación Sanitaria y Biomédica de Alicante · Updated on 2025-02-19
42
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo. Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.
CONDITIONS
Official Title
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with influenza A or B by antigen test or RT-PCR within 48 hours before randomization
- Hospitalized with an expected stay longer than 24 hours
- Receiving or starting treatment with oseltamivir
- Women of childbearing age must use contraception until 30 days after treatment ends
- Signed informed consent
You will not qualify if you...
- Bronchial hyperresponsiveness requiring systemic corticosteroids for more than 24 hours
- Prior corticosteroid treatment for more than 24 hours at high doses (1 mg/kg methyl-prednisolone or equivalent)
- Unable to take oral oseltamivir
- Currently on extracorporeal membrane oxygenation (ECMO)
- Pre-existing condition or medication posing risk for corticosteroid use as judged by investigator
- Severe comorbidity with life expectancy under six months
- Co-infection with SARS-CoV-2 or RSV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)
Alicante, Spain
Actively Recruiting
2
Hospital General Universitario de Elche
Elche, Spain
Actively Recruiting
Research Team
J
Javier Mateo, Biologist
CONTACT
L
Livia Giner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here