A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza, Human

In brief

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

Key facts

Study ID: NCT01231620
Run by: GlaxoSmithKline
People needed: 626
Starts: 2011-01-15
Expected to finish: 2015-03-18
Last updated by the study team: 2018-10-15

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female aged 16 years; a female is eligible to enter and participate in the study if she is:
of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post- menopausal); or,
of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to use protocol specified methods of birth control while on study.
Vital signs criteria defined as 3 or more of the following at Baseline:
Presence of fever [oral temperature of 38°C or equivalent] at Baseline. However, this requirement is waived if the subject has a history of fever within in the 24 hours prior to Baseline; or, if the subject reported symptoms of feverishness at some time during the 48 hours prior to Baseline.
AND at least 2 out of the following 4:
Oxygen saturation <95% on room air by trans-cutaneous method or need for any supplemental oxygenation or ventilatory support, 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 oxygen saturation of at least 3% below the patient's historical baseline oxygen saturation will satisfy this criterion.
Respiration rate >24 breaths per minute. For those subjects who require ventilatory support or oxygen supplementation, this requirement is waived.
Heart rate >100 beats per minute.
Systolic blood pressure <90 mmHg.
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.
Clinical symptoms of influenza with positive influenza diagnostic test result or strong suspicion of influenza illness based on clinical symptoms and local surveillance information.
Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol, or legally acceptable representative willing and able to give written informed consent on behalf of the subject for minors, unconscious adults and those incapable of consenting themselves due to their medical condition, or included as permitted by local regulatory authorities, IRB/IECs or local laws.
Severity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive care
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

You may not qualify if…

Subjects who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.
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 with creatinine clearance ≤10 mL/min who are not being treated with continuous renal replacement therapy (CRRT).
Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline
Subjects who require routine/intermittent hemodialysis or continuous peritoneal dialysis (due to inability to provide appropriate dosing schedule for oseltamivir) at Baseline. CRRT modalities are allowed.
Liver toxicity criteria based on local laboratory results obtained within 24 hours of Baseline:
ALT or AST 3xULN and bilirubin 2xULN
ALT 5xULN
Underlying chronic liver disease with evidence of severe liver impairment.
History of severe 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.
Females who are pregnant or are breastfeeding.
Treatment with investigational parenteral anti-influenza drugs (IV peramivir, IV zanamivir or IV oseltamivir) in the 4 weeks prior to Baseline.
French and Korean subjects: the French or Korean subject has participated in any study using an investigational drug during the previous 30 days.

Where it is running

GSK Investigational Site — Phoenix, Arizona, United States
GSK Investigational Site — Chula Vista, California, United States
GSK Investigational Site — Escondido, California, United States
GSK Investigational Site — Fullerton, California, United States
GSK Investigational Site — La Jolla, California, United States
GSK Investigational Site — La Mesa, California, United States
GSK Investigational Site — Oceanside, California, United States
GSK Investigational Site — Aurora, Colorado, United States
GSK Investigational Site — Stamford, Connecticut, United States
GSK Investigational Site — Orlando, Florida, United States
GSK Investigational Site — Sarasota, Florida, United States
GSK Investigational Site — Sunrise, Florida, United States
GSK Investigational Site — Atlanta, Georgia, United States
GSK Investigational Site — Augusta, Georgia, United States
GSK Investigational Site — Idaho Falls, Idaho, United States
GSK Investigational Site — Chicago, Illinois, United States
GSK Investigational Site — Oak Park, Illinois, United States
GSK Investigational Site — Peoria, Illinois, United States
GSK Investigational Site — Council Bluffs, Iowa, United States
GSK Investigational Site — Topeka, Kansas, United States
GSK Investigational Site — Louisville, Kentucky, United States
GSK Investigational Site — Boston, Massachusetts, United States
GSK Investigational Site — Royal Oak, Michigan, United States
GSK Investigational Site — Troy, Michigan, United States
GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.