New hope for tiniest flu patients: IV zanamivir tested in infants under 6 months
NCT ID NCT04494412
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Arthralgia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can mRNA technology outsmart the flu in older adults?
- One shot, two protections? a new vaccine aims to tackle flu and COVID together
- Can a lab-made flu vaccine outperform the traditional egg-based shot?
- Bedside flu shot for heart patients: a simple strategy to save lives?
- Online pain coping skills may ease joint pain in breast cancer survivors
- New adjuvanted flu vaccine aims to boost protection in older adults