IV zanamivir treatment for hospitalized infants with influenza

An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection

This study is testing if an intravenous flu medication called zanamivir is safe and helpful for hospitalized infants under 6 months old who have the flu.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: N/A to 6 Months
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Locations: 9 sites (Florence and 8 other locations)
• Trial ID: NCT04494412 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, safety, and tolerability of intravenous zanamivir in hospitalized neonates and infants under 6 months old who are infected with influenza. It is an open-label, multi-center, single-arm study aimed at addressing the unmet medical need for effective antiviral treatment in this vulnerable population. Participants will be monitored for their response to the treatment, and data will be collected to assess the drug's effectiveness and safety profile in young patients. The study is part of a broader effort to improve influenza management in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized neonates and infants under 6 months of age diagnosed with influenza.

Not a fit: Patients who are not hospitalized or are older than 6 months will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for hospitalized neonates and infants suffering from influenza, potentially reducing morbidity and mortality in this age group.

How similar studies have performed: While there have been successful studies on zanamivir in older populations, this specific approach for infants under 6 months is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Florence and 8 other locations

• GSK Investigational Site — Florence, Italy (Recruiting)
• GSK Investigational Site — Messina, Italy (Recruiting)
• GSK Investigational Site — Milan, Italy (Recruiting)
• GSK Investigational Site — Roma, Italy (Recruiting)
• GSK Investigational Site — Bydgoszcz, Poland (Completed)
• GSK Investigational Site — Barcelona, Spain (Recruiting)
• GSK Investigational Site — Madrid, Spain (Recruiting)
• GSK Investigational Site — London, United Kingdom (Recruiting)
• GSK Investigational Site — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Influenza, Human; Arthralgia; Human influenza; Zanamivir; Pediatric; Hospitalized neonates and infants