drugset / Trial / NCT01231620
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-01-15
- Primary completion
- 2015-03-18
- Completion
- 2015-03-18
Outcome
Missed primary endpoint
paper Time to clinical response to intravenous zanamivir dosed at 600 mg was not superior to oseltamivir or 300 mg intravenous zanamivir. PMID 28094141 ↗
registry analysis (superiority or other test); IV Zanamivir 600 mg vs Oral Oseltamivir 75 mg; p = 0.39; Median Difference (Final Values) -0.48 (95% CI -2.11 to 0.97); Wilcoxon rank sum NCT01231620 ↗
Publications
- van Duijnhoven W, Van Dromme I, Haesendonckx S, Witek J, Leopold L. The Hospital Recovery Scale: A clinically useful endpoint in patients hospitalized with influenza. Contemp Clin Trials. 2022 Dec;123:106952. doi: 10.1016/j.cct.2022.106952. Epub 2022 Oct 3.
- Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oseltamivir | Small molecule | 75 mg | Oral |
| Subject | Zanamivir | Small molecule | 300 mg | Intravenous |
| Subject | Zanamivir | Small molecule | 600 mg | Intravenous |