New hope for tiniest flu patients: IV zanamivir tested in infants under 6 months

NCT ID NCT04494412

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study investigates the safety and how the body processes intravenous (IV) zanamivir in hospitalized infants under 6 months old with complicated influenza. Currently, no antiviral is approved for this age group, leaving them vulnerable. The trial will measure drug levels in the blood and monitor for side effects over up to 24 days, with treatment lasting up to 10 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanamivir
What this could lead to
If successful, this could provide a safe and effective antiviral treatment option for very young infants hospitalized with severe influenza.
What could go wrong
This is a small, early-phase study with only 8 participants, so results may not apply broadly. The drug's safety and effectiveness in this age group are still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

Nov 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. Preterm neonates and infants will be eligible for inclusion but must have reached PMA of at least 28 weeks. * Participants who are hospitalized with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative Reverse transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential for improvement Participants with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR. * Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). (applicable only for Netherlands) * Body weight \>=1 kilograms (kg). * No gender restriction. * LAR of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, Independent Ethics Committees \[IECs\] or local laws). Exclusion criteria: * Participants who are known or suspected to be hypersensitive to any component of the study medication. * Participants with a disease process which is likely to be irreversible. * Liver function: * Participants who meet the following criteria at Baseline: 1. Alanine transaminase (ALT) \>=3 times upper limit of normal (ULN) with bilirubin \>=2 times ULN 2. or isolated bilirubin \>=2 times ULN and \>50 percent (%) direct bilirubin 3. or ALT \>=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain). * Participants who require concurrent therapy with another anti influenza drug. * Participants who have participated in a study using an investigational drug within 30 days prior to Baseline. * Child in care (CiC), as defined below: * A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. * The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian. * Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration. * Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening

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Conditions

The condition(s) this trial relates to.

Arthralgia influenza

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Florence, 50139, Italy

  • GSK Investigational Site

    Messina, Italy

  • GSK Investigational Site

    Roma, 00165, Italy

  • GSK Investigational Site

    Bydgoszcz, 85-168, Poland

  • GSK Investigational Site

    Barcelona, 08950, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

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