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



Status:Completed
Conditions:Influenza, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:10/17/2018
Start Date:January 15, 2011
End Date:March 18, 2015

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A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

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.

The recent influenza pandemic has highlighted the need for alternative formulations for
anti-influenza therapies. This will be an international Phase III, double-blind,
double-dummy, 3-arm study to evaluate the efficacy, antiviral activity and safety of IV
zanamivir 600 mg twice daily compared to oral oseltamivir 75 mg twice daily, and 600 mg IV
zanamivir twice daily compared to 300 mg IV zanamivir for 5 days in hospitalized subjects
with laboratory confirmed or suspected influenza infection. For a given subject, the initial
5-day treatment course may be extended for up to 5 additional days if clinical symptoms or
patient characteristics as assessed by the investigator warrant further treatment.
Alternatively, if the investigator considers that a subject is failing to improve clinically
on their randomized treatment, the investigator can choose to initiate the switch/rescue
option (600 mg IV zanamivir twice daily) on any day from Day 6 through Day 10 for up to an
additional 5 days of treatment. On switching treatments, subjects complete a maximum of 14
days of treatment and are followed-up to Post-Treatment +28 Days.

Inclusion Criteria:

- Male or female aged 16 years; 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.

- Vital signs criteria defined as 3 or more of the following at Baseline:

1. 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:

2. 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.

3. Respiration rate >24 breaths per minute. For those subjects who require
ventilatory support or oxygen supplementation, this requirement is waived.

4. Heart rate >100 beats per minute.

5. 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

Exclusion Criteria:

- 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:

1. ALT or AST 3xULN and bilirubin 2xULN

2. 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.
We found this trial at
41
sites
Chapel Hill, North Carolina 27599
616
mi
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Chapel Hill, NC
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Asheville, North Carolina 28803
772
mi
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Asheville, NC
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Atlanta, Georgia 30341
923
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Atlanta, GA
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Augusta, Georgia 30909
856
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Augusta, GA
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Aurora, Colorado 80010
1756
mi
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Aurora, CO
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Bethlehem, Pennsylvania 18105
256
mi
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Bethlehem, PA
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Birmingham, Alabama 35249
1052
mi
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Birmingham, AL
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Bismarck, North Dakota 58501
1483
mi
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Bismarck, ND
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Boston, Massachusetts 02115
2
mi
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Boston, MA
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Chicago, Illinois 60611
845
mi
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Chicago, IL
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Chula Vista, California 91911
2574
mi
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Chula Vista, CA
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Cleveland, Ohio 44195
543
mi
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Cleveland, OH
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Columbus, Ohio 43219
634
mi
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Columbus, OH
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Council Bluffs, Iowa 51503
1272
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Council Bluffs, IA
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Escondido, California 92025
2558
mi
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Escondido, CA
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Fullerton, California 92835
2577
mi
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Fullerton, CA
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Houston, Texas 77030
1605
mi
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Houston, TX
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Idaho Falls, Idaho 83404
2051
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Idaho Falls, ID
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La Jolla, California 92093
2574
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La Jolla, CA
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La Mesa, California 91942
2566
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La Mesa, CA
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Las Vegas, Nevada 89102
2369
mi
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Las Vegas, NV
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Louisville, Kentucky 40202
821
mi
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Louisville, KY
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Marshfield, Wisconsin 54449
966
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Marshfield, WI
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Missoula, Montana 59807
2103
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Missoula, MT
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Oak Park, Illinois 60302
853
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Oak Park, IL
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Oceanside, California 92056
2567
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Oceanside, CA
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Orlando, Florida 32806
1115
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Orlando, FL
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Peoria, Illinois 61636
961
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Peoria, IL
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Philadelphia, Pennsylvania 19104
270
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Philadelphia, PA
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Phoenix, Arizona 85012
2290
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Roanoke, Virginia 24013
585
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Roanoke, VA
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Royal Oak, Michigan 48073
614
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Royal Oak, MI
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Saint Louis, Missouri 63110
1036
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Saint Louis, MO
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Sarasota, Florida 34232
1219
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Sarasota, FL
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Stamford, Connecticut 06902
155
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Stamford, CT
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Sunrise, Florida 33323
1234
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Sunrise, FL
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Toledo, Ohio 43608
639
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Toledo, OH
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Topeka, Kansas 66604
1305
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Topeka, KS
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Troy, Michigan 48085
611
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Troy, MI
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Valhalla, New York 10595
164
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Valhalla, NY
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Westmead, New South Wales 2145
10097
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Westmead,
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