Overview

A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection

Status:
Completed
Trial end date:
2013-03-29
Target enrollment:
0
Participant gender:
All
Summary
This study will be an open-label, multi-center, single arm study to evaluate the safety and efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with laboratory confirmed influenza infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Zanamivir
Criteria
Inclusion Criteria:

- Male or female aged greater than or equal to 16 years 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 use protocol specified methods of birth control while on study.

- Subjects who have laboratory confirmed influenza as determined by a positive result in
a rapid antigen test (RAT) for influenza A or influenza B, or a laboratory test for
influenza including but not limited to influenza virus antigen test, virus culture or
RT-PCR test.

- Presence of fever [oral temperature of >=38 deg C, rectal, tympanic of >=38.5 deg C or
axilla >=37.4 deg C] at Baseline. However, this requirement is waived if the subject
has a history of fever within the 48 hours prior to Baseline and has been administered
any antipyretic(s) in the 48 hours prior to Baseline.

- Hospitalized subjects with symptomatic influenza as defined by ANY of the following.

1. Moderate to severe tachypnea (respiratory rate >=24/minute) OR

2. Moderate to severe dyspnea (unable to speak in full sentences) OR

3. Arterial oxygen saturation <95% on room air by trans-cutaneous method, or need
for any supplemental oxygenation or ventilatory support [mechanical ventilation,
bi-level positive airway pressure (bipap), continuous positive airway pressure
(cpap)], or increase in oxygen supplementation requirement of >=2 litres for
subjects with chronic oxygen dependency. For those subjects with a history of
chronic hypoxia (without supplemental oxygen), an arterial oxygen saturation of
at least 3% below the patient's historical baseline oxygen saturation will
satisfy this criterion OR

4. Hemodynamic instability, defined as systolic blood pressure <90 mmHg or heart
rate >100 beats per minute OR

5. Subject who became dehydrated and need whole-body management by hospitalization.

- Onset of influenza symptoms within 6 days prior to study enrolment. Symptoms may
include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms
(rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.

- Subjects/legally acceptable representative of unconscious adults willing and able to
give written informed consent to participate in the study, and subjects willing to
adhere to the procedures stated in the protocol.

Exclusion Criteria:

- Subjects who, in the opinion of the investigator, are not likely to survive beyond 48
hours from Baseline.

- Subjects who are considered to require concurrent therapy with another influenza
antiviral medication.

- Subjects who are known or suspected to be hypersensitive to any component of the study
medications.

- Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline (enrolled
subject who subsequently require ECMO may continue in the study).

- Liver toxicity criteria based on local laboratory results obtained at Baseline:

1. ALT or AST >=3xULN and bilirubin >=2xULN

2. ALT >=5xULN

- Underlying chronic liver disease with evidence of severe liver impairment (Child-Pugh
Class C).

- History of severe cardiac disease or clinically significant arrhythmia (either on ECG
or by history) which, in the opinion of the investigator or sub-investigator, will
interfere with the safety of the individual subject.

- Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are
breastfeeding.

- QT criteria at Baseline as defined below:

1. QTcB or QTcF >480 msec

2. If a subject has bundle branch block then criteria is QTcB or QTcF >510 msec

- Subject has participated in any study using an investigational drug during the
previous 30 days.