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Study on the Effects of Dexamethasone and Oseltamivir in Patients with Severe Influenza

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients with severe influenza, commonly known as the flu. The study will compare the use of a medication called dexamethasone, which is a type of corticosteroid, with a placebo. Additionally, all patients will receive oseltamivir, an antiviral medication often used to treat influenza.

The purpose of the study is to evaluate how effective and safe dexamethasone is when used alongside oseltamivir in treating severe cases of the flu. Participants in the study will be randomly assigned to receive either the combination of dexamethasone and oseltamivir or oseltamivir with a placebo. The study will monitor patients over a period of time to assess their recovery and any side effects they may experience.

Throughout the study, researchers will observe the patients' health status, including whether they need additional oxygen, intensive care, or mechanical ventilation. The study aims to provide valuable information on whether adding dexamethasone to the standard flu treatment can improve outcomes for patients with severe influenza.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication dexamethasone along with oseltamivir, and the other group will receive a placebo with oseltamivir. This process is called randomization and ensures that the trial results are unbiased.

  2. Step 2

    Medication administration

    You will take the medications orally. The specific dosage and frequency will be provided by the medical team overseeing the trial. The duration of the medication administration will be determined based on your response and the trial protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored. This includes regular assessments to evaluate your recovery status using the Hospital Recovery Scale. The primary focus is on your condition on day 7 after starting the treatment.

    Additional assessments will include measuring your clinical stability, hospital stay duration, and any need for intensive care or mechanical ventilation. These assessments help determine the effectiveness and safety of the treatment.

  4. Step 4

    Follow-up visits

    Follow-up visits will occur at specific intervals, such as 30 and 90 days after treatment completion. During these visits, your dependency and frailty levels will be evaluated using standardized scales. These evaluations help understand the long-term impact of the treatment on your daily living activities.

  5. Step 5

    End of trial participation

    At the end of your participation in the trial, a final assessment will be conducted. This will include a review of your overall health status and any changes observed during the trial period. The information gathered will contribute to the overall findings of the study.

Who can join the trial?

6 criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of influenza A or B virus infection. This can be done by a test that detects the virus, such as an antigen test or RT-PCR, using a sample from your nose or lungs.
  • Must be hospitalized with an expected stay of more than 24 hours.
  • Must be currently receiving or starting treatment with oseltamivir, a medication used to treat influenza.
  • If you are a woman who can become pregnant, you must use contraceptive methods until 30 days after finishing the treatment.
  • Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

9 criteria

  • Patients who are not experiencing severe influenza cannot participate.
  • Patients who are under the age of 18 or over the age of 65 cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to oseltamivir or dexamethasone cannot participate. Oseltamivir is a medication used to treat influenza, and dexamethasone is a type of steroid medication.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a history of severe allergic reactions to any medication cannot participate.
  • Patients with a compromised immune system, meaning their body's defense against infections is weakened, cannot participate.
  • Patients with severe liver or kidney disease cannot participate.
  • Patients who have been hospitalized for influenza with a status of 3 or higher on the Hospital Recovery Scale cannot participate. This scale measures the severity of a patient's condition, with status 3 being hospitalization with supplemental oxygen, status 4 being ICU admission without invasive mechanical ventilation, status 5 being with invasive mechanical ventilation, and status 6 being death.
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Investigated drugs

  • Dexamethasone

    is a medication that helps reduce inflammation in the body. In this clinical trial, it is being tested to see if it can help patients with severe influenza recover more quickly. The goal is to see if adding dexamethasone to the usual treatment can improve the health of patients who are hospitalized with severe flu symptoms.

  • Oseltamivir

    is an antiviral medication commonly used to treat influenza. It works by stopping the flu virus from spreading in the body, which can help reduce the severity and duration of flu symptoms. In this trial, oseltamivir is part of the standard treatment given to all patients to help fight the influenza virus.

What is already known about the treatment

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is currently being studied in clinical trials for its effectiveness in treating severe influenza. It is a well-known medication in the medical field, primarily used for its anti-inflammatory and immunosuppressant properties. The main therapeutic indication for dexamethasone in this trial is to reduce the severity of symptoms in patients with severe influenza. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which leads to a decrease in the production of substances that cause inflammation. It is classified pharmacologically as a corticosteroid.

  • Oseltamivir

    Oseltamivir is taken orally in the form of capsules or liquid and is widely recognized in medical literature as an antiviral medication used to treat and prevent influenza. In the context of this clinical trial, it is used in combination with dexamethasone or a placebo to assess its effectiveness in severe cases of influenza. Oseltamivir works by inhibiting the neuraminidase enzyme, which is essential for the influenza virus to spread within the body. It is classified as a neuraminidase inhibitor.

Investigated diseases

Severe Influenza – Severe influenza is a viral infection that affects the respiratory system, caused by the influenza virus. It begins with symptoms such as fever, cough, sore throat, muscle aches, and fatigue. As the disease progresses, it can lead to more severe respiratory symptoms, including difficulty breathing and chest pain. In some cases, it may cause complications like pneumonia or exacerbate existing chronic conditions. The disease can lead to hospitalization, especially in vulnerable populations such as the elderly or those with weakened immune systems. Recovery can vary, with some individuals experiencing prolonged symptoms or requiring intensive medical care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513209-30-00Protocol codeFLUDEXEstimated enrolment486 patientsSponsorFundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante

sourced from the EU Clinical Trials Register and site verification

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