Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: zanamivir aqueous solution
Intervention description: Zanamivir aqueous solution 10mg/mL is a clear, colorless, single use, sterile non-preserved preparation containing 10mg of zanamivir in each milliliter, and made isotonic with sodium chloride. It is presented in 20mL clear glass vials closed with rubber stoppers. Each vial contains 200mg of zanamivir.
Intervention MeSH terms: Zanamivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: pandemic; seasonal influenza; Influenza B virus; H1N1; zanamivir; Influenza A virus, H1N1 Subtype; Relenza; influenza; neuraminidase inhibitor

Summary:

      The purpose of this study is to determine whether zanamivir aqueous solution given by
      intravenous injection is safe in treating hospitalized patients with confirmed influenza
      infection. A single arm open-label design has been selected to achieve the primary objective
      of providing regulatory authorities with safety data on IV zanamivir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged greater than or equal to 6 months of age; a female is eligible to
             enter and participate in the study if she is:

               1. of non-childbearing potential (i.e., physiologically incapable of becoming
                  pregnant, including any female who is post-menopausal); or,

               2. of child-bearing potential, has a negative pregnancy test at Baseline, and agrees
                  to one of the following methods for avoidance of pregnancy during the study and
                  until the Post-Treatment +23 Days Follow-up Assessment:

          -  Abstinence; or,

          -  Oral contraceptive, either combined or progestogen alone; or,

          -  Injectable progestogen; or,

          -  Implants of levonorgestrel; or,

          -  Estrogenic vaginal ring; or,

          -  Percutaneous contraceptive patches; or

          -  Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected
             failure rate is less than 1% per year as stated in the IUD or IUS Product Label; or,

          -  Has a male partner who is sterilized; or,

          -  Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps)
             with a vaginal spermicidal agent (foam/gel/film/cream/suppository).

          -  Subjects who have confirmed influenza as determined by a positive result in a rapid
             test for influenza A or influenza B, or a laboratory test for influenza including
             influenza virus antigen test, virus culture or RT-PCR test. Subjects with negative
             rapid test result suspected of having influenza can be enrolled following confirmatory
             testing by RT-PCR, antigen test or culture.

          -  Hospitalized subjects with symptomatic influenza

          -  Subjects who are able to receive their first dose of study medication within seven
             days of experiencing influenza-like symptoms.

          -  Subjects willing and able to adhere to the procedures stated in the protocol.

          -  Subjects/legally acceptable representative (LAR) of minors and unconscious adults
             willing and able to give written informed consent to participate in the study (or
             included as permitted by local regulatory authorities, IRBs/IECs or local laws).

          -  French subjects: In France, a subject will be eligible for inclusion in this study
             only if either affiliated to or a beneficiary of a social security category.

          -  UK subjects and subjects in Spain: Subjects should be in a high dependency or
             intensive care setting at the time of enrollment and either have severe and
             progressive illness on approved influenza antivirals, or are considered unsuitable for
             treatment with approved influenza antivirals.

          -  Subjects who have severe or progressive influenza illness on approved (fully licensed)
             influenza antivirals, or who are considered unsuitable or inappropriate for treatment
             with approved influenza antivirals, or who in the opinion of the investigator may
             benefit from IV zanamivir therapy.

        Exclusion Criteria:

          -  Subjects who, in the opinion of the investigator, are not likely to survive the next
             48 hours beyond Baseline.

          -  Subjects who require concurrent therapy with another influenza antiviral drug.

          -  Subjects who have participated in a study using an investigational influenza antiviral
             drug within 30 days prior to Baseline.

          -  Subjects who are known or suspected to be hypersensitive to any component of the study
             medication.

          -  Subjects who meet the following criteria at Baseline:

          -  ALT greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN or ALT
             greater than or equal to 5xULN

          -  History of cardiac disease or clinically significant arrhythmia (either on ECG or by
             history) which, in the opinion of the Investigator, will interfere with the safety of
             the individual subject.

          -  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.

          -  French subjects: the French subject has participated in any study using an
             investigational drug during the previous 30 days.

          -  Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are
             breastfeeding.