CompletedPhase 3

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

United States626 participantsStarted 2011-01-15

Plain-language summary

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.

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.
✓. 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.

Exclusion criteria

✕. ALT or AST 3xULN and bilirubin 2xULN
✕. ALT 5xULN

What they're measuring

Time to Clinical Response (TTCR) in Participants With Confirmed Influenza

Timeframe: Up to 42 days

Trial details

NCT IDNCT01231620

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03-18

Results submitted2017-04-11

View on ClinicalTrials.gov More Influenza, Human trials