Hospitalized adult, adolescent and pediatric subjects with influenza infection. MedDRA version: 12.0 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Product Name: IV zanamivir
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: zanamivir
CAS Number: 139110-80-8
Current Spo
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged > 6 months of age; a female is eligible to enter and participate in the study if she is: a. of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, b. known to be pregnant at Baseline; or, c. 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). 2. 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. 3. Hospitalized subjects with symptomatic influenza as defined by ANY of the following: • Evidence of lower respiratory tract infection by one of the following: o New infiltrate on chest radiograph o Oxygen saturation 5% less than patient’s baseline if known underlying lung disease o 15 mmHg or greater decrease in alveoloar-arterial oxygen gradient compared to the patient’s known or expected baseline gradient o Symptoms associated with respiratory distress (e.g. dyspnea) • Signs and symptoms consistent with influenza requiring hospitalization. • Presence of fever at time of screening of = 38.0 °C (= 100.0 °F) taken orally, or = 38.5 °C (= 101.2 °F) taken rectally. However, this requirement is waived (1) if the subject has a history of fever within the 24 hours prior to screening and has been administered any antipyretic(s) in the 24 hours prior to screening, or (2) if the subject has no history of documented fever as defined above, but reports a symptom of feverishness at some time during the 48 hours prior to screening. 4. Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms. 5. Subjects anticipated to require hospitalization for 5 or more days. 6. Subjects willing and able to adhere to the procedures stated in the protocol. 7. Subjects/legally acceptable representative (LAR) of minors and unconscious adults willing and able to give written informed co
Exclusion criteria
Exclusion criteria: 1. Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline. 2. Subjects who require concurrent therapy with another influenza antiviral drug. 3. Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline. 4. Subjects who are known or suspected to be hypersensitive to any component of the study medication. 5. Subjects who meet the following criteria at Baseline: ALT > 3xULN and bilirubin > 2xULN or ALT > 5xULN 6. 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. 7. QT criteria at baseline as defined below: • QTcB or QTcF > 500 msec • If subject has bundle branch block then criteria is QTcB or QTcF > 530 msec 8. Child in care (CiC) as defined below: A child who has been placed under the control or protection of an agency, organisation, 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. 9. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of IV zanamivir in the treatment of hospitalized adult, adolescent and pediatric subjects with influenza infection.; Secondary Objective: • To evaluate the serum pharmacokinetics of IV zanamivir in a subset of hospitalized adult, adolescent and pediatric subjects with influenza infection. • To assess viral load (from nasopharyngeal swabs) in hospitalized subjects with influenza infection following treatment with IV zanamivir. • To evaluate the clinical course of illness in hospitalized subjects with influenza infection following treatment with IV zanamivir. • To evaluate viral susceptibility and resistance to zanamivir. ; Primary end point(s): • Adverse events. These will be coded using MedDRA and summarized by system organ class and preferred term for: i) the overall incidence of adverse events, ii) the incidence of adverse events considered to be related to study treatment iii) the incidence of grade 3/4 or severe adverse events iv) the incidence of adverse events leading to discontinuation of study drug v) the incidence of adverse events leading to discontinuation from the study vi) the incidence of serious adverse events vii) the incidence of treatment-related serious adverse events viii) the incidence of severe or grade 3 and 4 treatment-related adverse events. ix) the incidence of fatal serious adverse events • Clinical laboratory data: Clinical chemistry and hematology data will be listed, flagging values outside the normal range. Clinical laboratory data will also be summarized based on changes from baseline and toxicity shifts from baseline. Summary of treatment emergent laboratory toxicities by intensity will be tabulated for each lab parameter. | — |
Countries
France, Germany, Spain, United Kingdom
Outcome results
None listed