InfluenzaPhase 3FLUDEXNCT06528444
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
A Phase 3 study testing Grup 2 dexametasona in people with Influenza, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Grup 2 dexametasona
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2024to 31 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years.
- Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
- Hospitalized patients with an estimated hospital stay of more than 24 hours.
- In previous treatment or concomitant start of treatment with oseltamivir.
- For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
- Signed informed consent.
Who cannot join
- 1. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
- 2. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).
- 3. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.
- 6. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
- 7. Patients co-infected with SARS-CoV-2 or RSV.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Livia Giner contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)
Alicante
Juan Cebollada
- Recruiting
Hospital General Universitario de Elche
Elche
Cati Robledano
About this study
Official title: Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
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
- Influenza
- Being tested
- Grup 1 placebo, Grup 2 dexametasona
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grup 1 placeboDrug
placebo 1 capsule (6 mg) /day for 7 days.
Grup 2 dexametasonaDrug
dexamethasone 1 capsule (6 mg)/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo 1 capsule (6 mg) /day for 7 days. Receives: Drug: Grup 1 placebo |
| dexamethasone | Active comparator | dexamethasone 1 capsule (6 mg)/day for 7 days Receives: Drug: Grup 2 dexametasona |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the percentage of patients hospitalized
To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.
Measured: 10 days
Secondary outcomes (15)
The National Early Warning Score
To compare the time, in days, between initiation of treatment and clinical stability according to the NEWS2<2 scale for 24 hours or until hospital discharge, taking the value of the first of the two events to occur
Measured: 10 days
Common Terminology Criteria for Adverse Events (CTCAE) scale
To compare the frequency of serious adverse effects between groups (grades 3, 4 and 5 on the CTCAE scale).
Measured: 10 days
Rate of metabolic impact of dexamethasone
To evaluate the metabolic impact of dexamethasone by comparing the function of occurrence of sustained hyperglycemia level 1 and 2, and episodes of hyperglycemia during and at the end of dexamethasone treatment.
Measured: 10 days
the average hospital stay
To compare the average hospital stay (expressed in days) according to treatment group.
Measured: 10 days
Number of pacients in ICU admission
To compare the function of occurrence over time of clinical failure, defined as progression to: need for ICU admission, need for intubation or death.
Measured: 10 days
mortality
To compare mortality at days 10, 30 and 90 post-randomization.
Measured: 90 days
the impact of treatment Barthel Index
To evaluate the impact of treatment on dependency (Barthel Index) at the time of discharge or at the end of treatment, and at 30 and 90 days after randomization.
The final score ranges from 0 to 100, with 100 being the maximum independence and 0 being the maximum dependence.
Measured: 90 days
the impact of treatment Clinical Frailty Score
To evaluate the impact of treatment on frailty (Clinical Frailty Score) at the time of discharge or at the end of treatment, and at 30 and 90 days after randomization.
. level descriptions and their corresponding labels. Most notably, CFS level 2 changed from "Well" to "Fit", level 4 from "Vulnerable" to "Living with Very Mild Frailty", and levels 5-8 were restated as "Living with..." mild, moderate, severe, and very severe frailty, respectively
Measured: 90 days
To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.
To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.
Using NGS and then the consecutive bioinformatic analysis. More specifically, the alpha diversity would be the result of the Shannon Index and the number of ASVs (Amplicon sequence variant).
Measured: 10 days
the kinetics of influenza virus in nasopharyngeal swabs using Ct
To evaluate the kinetics of influenza virus in nasopharyngeal swabs (using Ct and ) in both groups.
Measured: 10 days
the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell
To evaluate the kinetics of influenza virus in nasopharyngeal swabs (viral quantification per human cell) in both groups.
Measured: 10 days
Evaluation inflammatory markers CRP
Evaluation the impact of treatment on inflammatory markers CRP
Measured: 10 days
Evaluation inflammatory markers PCT
Evaluation the impact of treatment on inflammatory markers PCT
Measured: 10 days
Evaluation inflammatory markers IL-6
Evaluation the impact of treatment on inflammatory markers IL-6
Measured: 10 days
Evaluation inflammatory markers IL-10
Evaluation the impact of treatment on inflammatory markers IL-10
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Oct 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de Alicante
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528444
- Sponsor's protocol ID
- FLUDEX
- Acronym
- FLUDEX
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-RIncon JM, Cebollada J, Giner L, Paz Ventero M, Moreno-Perez O, Otero-Rodriguez S, Sanchez-Paya J, Rodriguez JC, Merino E. Efficacy and safety of dexamethasone compared to placebo in patients with severe influenza infection. (FLUDEX study): a study protocol for a randomised controlled trial in Spain. BMJ Open. 2025 Sep 26;15(9):e103119. doi: 10.1136/bmjopen-2025-103119.
PubMed 41005772
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
- ClinicalTrials.gov ID
- NCT06528444
- Acronym / sponsor ID
- FLUDEX / FLUDEX
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de AlicanteResearch network
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Grup 1 placeboplacebo 1 capsule (6 mg) /day for 7 days. |
| dexamethasone | Active comparator | Drug: Grup 2 dexametasonadexamethasone 1 capsule (6 mg)/day for 7 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years.
- Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
- Hospitalized patients with an estimated hospital stay of more than 24 hours.
- In previous treatment or concomitant start of treatment with oseltamivir.
- For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
Key exclusion criteria (5 listed)
- 1. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
- 2. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).
- 3. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.
- 6. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
- 7. Patients co-infected with SARS-CoV-2 or RSV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grup 1 placeboplacebo 1 capsule (6 mg) /day for 7 days. | Drug | Placebo |
| Grup 2 dexametasonadexamethasone 1 capsule (6 mg)/day for 7 days | Drug | dexamethasone |
Primary outcome
To compare the percentage of patients hospitalized
Time frame: 10 days
To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.
15 secondary outcomes
The National Early Warning Score
Time frame: 10 days
Common Terminology Criteria for Adverse Events (CTCAE) scale
Time frame: 10 days
Rate of metabolic impact of dexamethasone
Time frame: 10 days
the average hospital stay
Time frame: 10 days
Number of pacients in ICU admission
Time frame: 10 days
mortality
Time frame: 90 days
the impact of treatment Barthel Index
Time frame: 90 days
the impact of treatment Clinical Frailty Score
Time frame: 90 days
To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.
Time frame: 10 days
the kinetics of influenza virus in nasopharyngeal swabs using Ct
Time frame: 10 days
the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell
Time frame: 10 days
Evaluation inflammatory markers CRP
Time frame: 10 days
Evaluation inflammatory markers PCT
Time frame: 10 days
Evaluation inflammatory markers IL-6
Time frame: 10 days
Evaluation inflammatory markers IL-10
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 41005772Ramos-RIncon JM, Cebollada J, Giner L, Paz Ventero M, Moreno-Perez O, Otero-Rodriguez S, Sanchez-Paya J, Rodriguez JC, Merino E. Efficacy and safety of dexamethasone compared to placebo in patients with severe influenza infection. (FLUDEX study): a study protocol for a randomised controlled trial in Spain. BMJ Open. 2025 Sep 26;15(9):e103119. doi: 10.1136/bmjopen-2025-103119.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Livia Giner contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grup 2 dexametasona in people with Influenza, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Mateo, Biologist (965 ext. 913972, mateo_jav@isabial.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the percentage of patients hospitalized (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.