<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494412</url>
  </required_header>
  <id_info>
    <org_study_id>200925</org_study_id>
    <nct_id>NCT04494412</nct_id>
  </id_info>
  <brief_title>An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza infection is an important public health priority, with seasonal outbreaks and&#xD;
      pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD),&#xD;
      safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants&#xD;
      more than or equal to (&gt;=) 6 months of age with hospitalized influenza in the IV zanamivir&#xD;
      global development program. However, antiviral treatment of neonates and infants under 6&#xD;
      months of age hospitalized with influenza infection remains a medical unmet need. Given the&#xD;
      immaturity of the immune system at this age, there are no licensed influenza vaccines for&#xD;
      children aged less than six months old. As a requirement of the Pediatric Investigation Plan&#xD;
      European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center,&#xD;
      single arm, post-marketing authorization study to evaluate the PK and collect safety and&#xD;
      tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months&#xD;
      of age with confirmed complicated influenza infection. The total duration of study&#xD;
      participation for each participant will be up to 24 days with a study treatment period up to&#xD;
      10 days and 14 days of post-treatment follow up. However, for a given participant, the&#xD;
      initial 5-day treatment course may be extended for up to 5 additional days if clinical&#xD;
      symptoms, participant characteristics or virological tests as assessed by the investigator&#xD;
      warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2022</start_date>
  <completion_date type="Anticipated">December 11, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 11, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label, multi-center and single arm study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve (AUC) of zanamivir</measure>
    <time_frame>Up to 12 hours after end of infusion on Day 1</time_frame>
    <description>Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of zanamivir</measure>
    <time_frame>Up to 12 hours after end of infusion on Day 1</time_frame>
    <description>Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL) in plasma following administration of zanamivir</measure>
    <time_frame>30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5</time_frame>
    <description>Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2) of zanamivir</measure>
    <time_frame>30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5</time_frame>
    <description>Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)</measure>
    <time_frame>From start of treatment (Day 1) up to Day 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in heart rate</measure>
    <time_frame>From start of treatment (Day 1) up to Day 24</time_frame>
    <description>Number of participants with abnormal findings for heart rate will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in Oxygen Saturation</measure>
    <time_frame>From start of treatment (Day 1) up to Day 24</time_frame>
    <description>Number of participants with abnormal findings for Oxygen Saturation will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in respiration rate</measure>
    <time_frame>From start of treatment (Day 1) up to Day 24</time_frame>
    <description>Number of participants with abnormal findings for respiration rate will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in body temperature</measure>
    <time_frame>From start of treatment (Day 1) up to Day 24</time_frame>
    <description>Number of participants with abnormal findings for body temperature will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load over time after administration of zanamivir</measure>
    <time_frame>Day 1 up to Maximum Day 24</time_frame>
    <description>Nasopharyngeal swab samples will be collected for assessing quantitative viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in viral load after administration of zanamivir</measure>
    <time_frame>Baseline (Day 1) and up to maximum Day 24</time_frame>
    <description>Nasopharyngeal swab samples will be collected for assessing quantitative viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with phenotypic resistance</measure>
    <time_frame>Up to Day 24</time_frame>
    <description>Nasopharyngeal swab samples will be collected for assessing phenotypic resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with genotypic resistance</measure>
    <time_frame>Up to Day 24</time_frame>
    <description>Nasopharyngeal swab samples will be collected for assessing genotypic resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with emergence of resistance to zanamivir</measure>
    <time_frame>Up to Day 24</time_frame>
    <description>Nucleotide sequence analysis will be carried out to determine emergence of resistance to zanamivir.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Arthralgia</condition>
  <arm_group>
    <arm_group_label>Hospitalized neonates and infants with influenza infection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preterm neonates and infants who have reached Post-Menstrual Age (PMA) of at least 28 weeks and have a confirmed complicated influenza infection will be included. Participants will receive daily IV infusion of zanamivir for up to 5 days. This initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests warrant further treatment. The initial dose of IV zanamivir will be determined by PMA/corrected age and body weight. The maintenance dose and interval between the initial dose and subsequent twice-daily maintenance dose will be further determined by Principal Investigator based on renal function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zanamivir</intervention_name>
    <description>Zanamivir 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.</description>
    <arm_group_label>Hospitalized neonates and infants with influenza infection</arm_group_label>
    <other_name>DECTOVA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates and infants who are aged less than 6 months (corrected age) at the time of&#xD;
             the informed consent signed by legally acceptable representative (LAR) of minors.&#xD;
             Preterm neonates and infants will be eligible for inclusion but must have reached PMA&#xD;
             of at least 28 weeks.&#xD;
&#xD;
          -  Participants who are hospitalized with influenza infection, confirmed by a positive&#xD;
             rapid molecular diagnostic test for influenza, or a local quantitative Reverse&#xD;
             transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential&#xD;
             for improvement Participants with negative rapid molecular test result suspected of&#xD;
             having influenza can be enrolled following confirmatory testing by quantitative&#xD;
             RT-PCR.&#xD;
&#xD;
          -  Participants with a high risk of altered oral drug absorption, represented by&#xD;
             multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating&#xD;
             physician). (applicable only for Netherlands)&#xD;
&#xD;
          -  Body weight &gt;=1 kilograms (kg).&#xD;
&#xD;
          -  No gender restriction.&#xD;
&#xD;
          -  LAR of minors are willing and able to give written informed consent to participate in&#xD;
             the study (or included as permitted by local regulatory authorities, Independent&#xD;
             Ethics Committees [IECs] or local laws).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participants who are known or suspected to be hypersensitive to any component of the&#xD;
             study medication.&#xD;
&#xD;
          -  Participants with a disease process which is likely to be irreversible.&#xD;
&#xD;
          -  Liver function:&#xD;
&#xD;
               -  Participants who meet the following criteria at Baseline:&#xD;
&#xD;
                    1. Alanine transaminase (ALT) &gt;=3 times upper limit of normal (ULN) with&#xD;
                       bilirubin &gt;=2 times ULN&#xD;
&#xD;
                    2. or isolated bilirubin &gt;=2 times ULN and &gt;50 percent (%) direct bilirubin&#xD;
&#xD;
                    3. or ALT &gt;=5 times ULN Inclusion of participants with liver function tests&#xD;
                       that fall outside these criteria must be discussed and agreed with the&#xD;
                       medical monitor.&#xD;
&#xD;
               -  Current or chronic history of liver disease or known hepatic or biliary&#xD;
                  abnormalities (with the exception of benign conditions such as Gilbert's&#xD;
                  syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be&#xD;
                  considered if appropriately managed according to local guidelines and must be&#xD;
                  discussed with the medical monitor (Not-applicable for Great Britain).&#xD;
&#xD;
          -  Participants who require concurrent therapy with another anti influenza drug.&#xD;
&#xD;
          -  Participants who have participated in a study using an investigational drug within 30&#xD;
             days prior to Baseline.&#xD;
&#xD;
          -  Child in care (CiC), as defined below:&#xD;
&#xD;
               -  A child who has been placed under the control or protection of an agency,&#xD;
                  organization, institution or entity by the courts, the government or a government&#xD;
                  body, acting in accordance with powers conferred on them by law or regulation.&#xD;
&#xD;
               -  The definition of a CiC can include a child cared for by foster parents or living&#xD;
                  in a care home or institution, provided that the arrangement falls within the&#xD;
                  definition above. The definition of a CiC does not include a child who is adopted&#xD;
                  or has an appointed legal guardian.&#xD;
&#xD;
          -  Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or&#xD;
             hemofiltration.&#xD;
&#xD;
          -  Participants who are positive for severe acute respiratory syndrome-related&#xD;
             coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Saskia de N Wildt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Piotr Korbal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Esplugues De Llobregat. Barcelona</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Mónica Balaguer Gargallo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Cristina Calvo Rey</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Clare Webster</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Soumendu Manna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human influenza</keyword>
  <keyword>Zanamivir</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Hospitalized neonates and infants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zanamivir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
    <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
    <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494412
org study id: 200925
nct id: NCT04494412
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label, multi-center and single arm study
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the serum concentration-time curve (AUC) of zanamivir
time frame: Up to 12 hours after end of infusion on Day 1
description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
measure: Maximum observed serum concentration (Cmax) of zanamivir
time frame: Up to 12 hours after end of infusion on Day 1
description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
measure: Clearance (CL) in plasma following administration of zanamivir
time frame: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5
description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
measure: Terminal half-life (t1/2) of zanamivir
time frame: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5
description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
measure: Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)
time frame: From start of treatment (Day 1) up to Day 24
description: 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.
measure: Number of participants with abnormal findings in heart rate
time frame: From start of treatment (Day 1) up to Day 24
description: Number of participants with abnormal findings for heart rate will be assessed.
measure: Number of participants with abnormal findings in Oxygen Saturation
time frame: From start of treatment (Day 1) up to Day 24
description: Number of participants with abnormal findings for Oxygen Saturation will be assessed.
measure: Number of participants with abnormal findings in respiration rate
time frame: From start of treatment (Day 1) up to Day 24
description: Number of participants with abnormal findings for respiration rate will be assessed.
measure: Number of participants with abnormal findings in body temperature
time frame: From start of treatment (Day 1) up to Day 24
description: Number of participants with abnormal findings for body temperature will be assessed.
measure: Viral load over time after administration of zanamivir
time frame: Day 1 up to Maximum Day 24
description: Nasopharyngeal swab samples will be collected for assessing quantitative viral load.
measure: Change From Baseline in viral load after administration of zanamivir
time frame: Baseline (Day 1) and up to maximum Day 24
description: Nasopharyngeal swab samples will be collected for assessing quantitative viral load.
measure: Number of participants with phenotypic resistance
time frame: Up to Day 24
description: Nasopharyngeal swab samples will be collected for assessing phenotypic resistance.
measure: Number of participants with genotypic resistance
time frame: Up to Day 24
description: Nasopharyngeal swab samples will be collected for assessing genotypic resistance.
measure: Number of participants with emergence of resistance to zanamivir
time frame: Up to Day 24
description: Nucleotide sequence analysis will be carried out to determine emergence of resistance to zanamivir.
arm group label: Hospitalized neonates and infants with influenza infection
arm group type: Experimental
description: Preterm neonates and infants who have reached Post-Menstrual Age (PMA) of at least 28 weeks and have a confirmed complicated influenza infection will be included. Participants will receive daily IV infusion of zanamivir for up to 5 days. This initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests warrant further treatment. The initial dose of IV zanamivir will be determined by PMA/corrected age and body weight. The maintenance dose and interval between the initial dose and subsequent twice-daily maintenance dose will be further determined by Principal Investigator based on renal function.
intervention type: Drug
intervention name: Zanamivir
description: Zanamivir 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.
arm group label: Hospitalized neonates and infants with influenza infection
other name: DECTOVA
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Netherlands
country: Poland
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Arthralgia
mesh term: Zanamivir
sharing ipd: Yes
ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/