An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorGlaxoSmithKline
About this trial
Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Alanine transaminase (ALT) >=3 times upper limit of normal (ULN) with bilirubin >=2 times ULN
or isolated bilirubin >=2 times ULN and >50 percent (%) direct bilirubin
Trial design
Design model
Single group
Treatments tested in this trial
Zanamivir
DrugZanamivir solution for infusion will be available as a 10 milligrams per milliliters (mg/mL) vial. DECTOVA is approved for age groups 6 months and above.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Hospitalized neonates and infants with influenza infectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Area under the serum concentration-time curve (AUC) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame
Up to 12 hours after end of infusion on Day 12
Maximum observed serum concentration (Cmax) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame
Up to 12 hours after end of infusion on Day 13
Clearance (CL) in plasma following administration of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame
30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 54
Terminal half-life (t1/2) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame
30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5Secondary outcomes
1
Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before.
Time frame
From start of treatment (Day 1) up to Day 242
Number of participants with abnormal findings in heart rate
Number of participants with abnormal findings for heart rate will be assessed.
Time frame
From start of treatment (Day 1) up to Day 243
Number of participants with abnormal findings in Oxygen Saturation
Number of participants with abnormal findings for Oxygen Saturation will be assessed.
Time frame
From start of treatment (Day 1) up to Day 244
Number of participants with abnormal findings in respiration rate
Number of participants with abnormal findings for respiration rate will be assessed.
Time frame
From start of treatment (Day 1) up to Day 24Sponsors and contacts
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Source ClinicalTrials.gov