Actively Recruiting
An Open Label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Clinical Outcomes of Intravenous Zanamivir in Neonates and Infants Under 6 Months With Complicated Influenza Infection
Led by GlaxoSmithKline · Updated on 2025-03-17
12
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Influenza infection poses a significant public health challenge due to seasonal outbreaks and pandemics causing widespread illness and death. This study focuses on hospitalized neonates and infants under 6 months of age with complicated influenza infection, a group with limited treatment options because their immune systems are immature and no licensed vaccines exist for this age. The study aims to evaluate the pharmacokinetics (PK), safety, and tolerability of intravenous (IV) zanamivir in this vulnerable population as part of a Pediatric Investigation Plan by GlaxoSmithKline. Participants who are hospitalized neonates and infants under 6 months, including preterm infants with at least 28 weeks post-menstrual age, will receive daily IV zanamivir infusions for up to 5 days. Depending on clinical symptoms, participant condition, or virological tests, this initial treatment may be extended for up to 5 additional days. The dosing is individually determined based on corrected age, body weight, and renal function, with the initial dose followed by twice-daily maintenance doses as guided by the principal investigator. Each participant will be involved in the study for up to 24 days, including a treatment period of up to 10 days and a 14-day post-treatment follow-up. Researchers will collect blood samples to measure zanamivir levels at various time points, monitor viral load changes, and assess safety by tracking adverse events and vital signs such as heart rate, oxygen saturation, respiration rate, and body temperature. The study also monitors for any emergence of resistance to zanamivir during the follow-up period to better understand treatment outcomes and safety in this young population.
CONDITIONS
Brief Title
An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates and infants younger than 6 months (corrected age) at the time of consent
- Preterm neonates and infants with a post-menstrual age of at least 28 weeks
- Hospitalized with confirmed influenza infection by rapid molecular test or RT-PCR
- Potential for clinical improvement assessed by investigator
- Body weight of at least 1 kilogram
- Legally acceptable representative able to provide written informed consent
- No gender restriction
You will not qualify if you...
- Known or suspected allergy to any component of the study medication
- Disease process likely to be irreversible
- Liver function abnormalities: ALT ≥3 times upper limit normal with bilirubin ≥2 times upper limit, or isolated bilirubin ≥2 times upper limit with >50% direct bilirubin
- Current or chronic liver disease except benign conditions like Gilbert's syndrome
- Concurrent treatment with another anti-influenza drug
- Participation in another investigational drug study within 30 days prior to baseline
- Child in care as defined by legal or governmental protection
- Undergoing extracorporeal membrane oxygenation (ECMO) or hemofiltration
- Positive for SARS-CoV-2 infection at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants receive daily intravenous infusions of zanamivir for up to 5 days. The treatment may be extended up to an additional 5 days based on clinical symptoms and test results. Dosage and frequency are adjusted according to age, weight, and renal function.
Daily visits for up to 10 days
Duration - Up to 19 days after treatment
Participants are monitored for safety and clinical outcomes after treatment ends, including assessment of adverse events, vital signs, and viral load up to Day 24.
Periodic visits or assessments up to Day 24
Trial Site Locations
Total: 9 locations
1
GSK Investigational Site
Florence, Italy, 50139
Actively Recruiting
2
GSK Investigational Site
Messina, Italy
Actively Recruiting
3
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
4
GSK Investigational Site
Roma, Italy, 00165
Actively Recruiting
5
GSK Investigational Site
Bydgoszcz, Poland, 85-168
Completed
6
GSK Investigational Site
Barcelona, Spain, 08950
Actively Recruiting
7
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
8
GSK Investigational Site
London, United Kingdom, SW17 0QT
Actively Recruiting
9
GSK Investigational Site
London, United Kingdom, W2 1NY
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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