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Study of intravenous zanamivir safety and effectiveness in infants under 6 months of age with complicated influenza infection

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What is this trial about?

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

This study focuses on treating complicated influenza infection in newborns and infants under 6 months of age who require hospital care. The study uses zanamivir, a medication given through an intravenous infusion (delivered directly into a vein through a small tube). This medicine is available under the brand name Dectova as a solution for infusion.

The purpose of this research is to understand how zanamivir works in the bodies of very young infants and newborns when given as a single dose and as multiple doses. The study will examine how the medicine moves through the body and check its safety in these young patients. All participants will receive the study medication - there is no placebo used in this study.

During the study, participants will receive the medication through an intravenous line for up to 10 days. The maximum daily dose will be 24 mg per kilogram of body weight. The healthcare team will monitor the patients and collect blood samples to measure how the medicine is processed by their bodies. This information will help determine the most appropriate dosing for young infants with severe flu infections.

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

    Initial confirmation

    Your influenza infection must be confirmed through a positive rapid molecular diagnostic test or a local quantitative RT-PCR test.

    If your rapid test is negative but influenza is suspected, you may still participate after confirmation through RT-PCR testing.

  2. Step 2

    Eligibility verification

    You must be under 6 months of age (corrected age) at the time of enrollment.

    If you were born prematurely, you must have reached at least 28 weeks post-menstrual age.

    Your body weight must be at least 1 kg.

    You must be hospitalized with influenza infection that has potential for improvement.

  3. Step 3

    Treatment administration

    You will receive Dectova (zanamivir), a medication given through an intravenous line (directly into your vein).

    The medication will be given as a 10 mg/mL solution for infusion.

    Multiple doses will be administered to reach a steady state in your body.

  4. Step 4

    Monitoring and measurements

    Your blood levels of the medication will be measured to determine:

    - How much medication reaches your bloodstream

    - The highest level of medication in your blood

    - How quickly your body processes the medication

    - How long the medication stays in your system

  5. Step 5

    Study duration

    The study will continue until December 2026.

    Your individual participation duration will be determined by your medical team based on your treatment needs.

Who can join the trial?

6 criteria

  • Must be a baby less than 6 months old at the time when the parent or legal guardian signs the consent form. For babies born early (premature), they must have reached at least 28 weeks of development from conception
  • Must be in the hospital with confirmed flu infection, proven by either: - A rapid molecular test showing positive results for flu, or - A special laboratory test called RT-PCR showing positive results
  • Must weigh at least 1 kilogram (2.2 pounds)
  • Can be either male or female
  • Must have a parent or legal guardian who can and is willing to provide written permission for the baby to participate in the study
  • Must have potential for health improvement

Who cannot join the trial?

12 criteria

  • Known hypersensitivity or allergy to zanamivir or any components of the medication
  • Participation in another clinical trial within the last 30 days
  • Presence of any severe medical condition that could interfere with the study, as determined by the study doctor
  • Babies who are not hospitalized
  • Age over 6 months
  • Kidney problems (severe renal impairment) that might affect how the medicine is processed by the body
  • Liver problems (severe hepatic dysfunction) that could impact medication metabolism
  • Babies who do not have confirmed influenza infection
  • Any condition that could make it unsafe for the baby to receive the study medication
  • Parents or legal guardians who are unable to provide informed consent
  • Known birth defects that could affect how the medication works in the body
  • Current use of other antiviral medications for influenza treatment
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Investigated drugs

Zanamivir (intravenous form) is an antiviral medication used to treat influenza (flu) infections. It works by blocking a protein that helps the flu virus spread within the body. When given through an IV (directly into the vein), this medication can help treat severe cases of flu, particularly in patients who cannot take oral medications. This formulation is especially important for treating complicated flu infections in very young patients, such as newborns and infants under 6 months of age who are sick enough to require hospital care.

What is already known about the treatment

Zanamivir - An antiviral medication administered intravenously (IV) that belongs to the class of neuraminidase inhibitors, specifically designed to treat influenza virus infections. The drug works by blocking the action of neuraminidase, a viral enzyme essential for the release of new virus particles from infected cells, thereby preventing the spread of the influenza virus throughout the body. Currently used in clinical settings for treating complicated influenza infections, particularly in hospitalized patients, and is being studied in neonates and infants under 6 months of age to better understand its pharmacokinetics and safety profile. This medication represents an important treatment option for severe cases of influenza, especially in situations where oral or inhaled medications may not be suitable.

Investigated diseases

Human Influenza - A highly contagious respiratory infection caused by influenza viruses that primarily affects the nose, throat, and lungs. The illness typically develops suddenly with symptoms including fever, muscle aches, fatigue, headache, and respiratory symptoms such as cough and runny nose. The virus spreads through tiny droplets made when infected people cough, sneeze, or talk. Symptoms usually appear within 1-4 days after exposure to the virus and most people recover within a week or two. The severity of symptoms can vary from mild to severe, with young children, elderly people, and those with weakened immune systems being more vulnerable to complications. The virus can cause seasonal epidemics, typically occurring during winter months in temperate regions.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-510663-34-00Protocol code200925Estimated enrolment11 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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