Evidence map›Paper›PMID 23983212›Full record

Trial reportThe Journal of infectious diseases2014

Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study.

Francisco M Marty, Choy Y Man, Charles van der Horst, Bruno Francois, Denis Garot, Rafael Mánez, Visanu Thamlikitkul, José A Lorente, Francisco Alvarez-Lerma, David Brealey and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01014988 (An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01014988 phase2completednot on this map

An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2015Enrolled202ConditionsInfluenza, HumanArmszanamivir aqueous solution
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Antiviral Drugs in Influenza.International journal of environmental research and public health · 2022
    Review
  10. Influenza Therapeutics in Clinical Practice-Challenges and Recent Advances.Cold Spring Harbor perspectives in medicine · 2021
    Review
  11. Article
  12. Article
  13. Oseltamivir-zanamivir combination therapy suppresses drug-resistant H1N1 influenza A viruses in the hollow fiber infection model (HFIM) system.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2018
    Article
  14. Article
  15. Article
  16. Review
  17. Antiviral Treatments.Clinics in chest medicine · 2017
    Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 6 countries.

Francisco M MartyDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts.
Choy Y Man
Charles van der Horst
Bruno Francois
Denis Garot
Rafael Mánez
Visanu Thamlikitkul
José A Lorente
Francisco Alvarez-Lerma
David Brealey
Henry H Zhao
Steve Weller
Phillip J Yates
Amanda F Peppercorn
Bellvitge University Hospital · ESBrigham and Women's Hospital · USCentre Hospitalier Universitaire de Tours · FRGlaxoSmithKline (India) · INGlaxoSmithKline (United Kingdom) · GBHospital Universitario de Getafe · ESInserm · FRJohns Hopkins University Center for AIDS ResearchParc de Salut · ESSiriraj Hospital · THUniversity College Hospital · GB

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410NIAID NIH HHS P30-AI50410-14
6 · The paper itself

Abstract

backgroundIntravenous zanamivir is a neuraminidase inhibitor suitable for treatment of hospitalized patients with severe influenza.

methodsPatients were treated with intravenous zanamivir 600 mg twice daily, adjusted for renal impairment, for up to 10 days. Primary outcomes included adverse events (AEs), and clinical/laboratory parameters. Pharmacokinetics, viral load, and disease course were also assessed.

resultsOne hundred thirty patients received intravenous zanamivir (median, 5 days; range, 1-11) a median of 4.5 days (range, 1-7) after onset of influenza; 83% required intensive care. The most common influenza type/subtype was A/H1N1pdm09 (71%). AEs and serious AEs were reported in 85% and 34% of patients, respectively; serious AEs included bacterial pulmonary infections (8%), respiratory failure (7%), sepsis or septic shock (5%), and cardiogenic shock (5%). No drug-related trends in safety parameters were identified. Protocol-defined liver events were observed in 13% of patients. The 14- and 28-day all-cause mortality rates were 13% and 17%. No fatalities were considered zanamivir related. Pharmacokinetic data showed dose adjustments for renal impairment yielded similar zanamivir exposures. Ninety-three patients, positive at baseline for influenza by quantitative polymerase chain reaction, showed a median decrease in viral load of 1.42 log10 copies/mL after 2 days of treatment.

conclusionsSafety, pharmacokinetic and clinical outcome data support further investigation of intravenous zanamivir. CLINICAL TRIALS REGISTRATION: NCT01014988.

Indexed as

Administration, IntravenousAdolescentAdultAgedAged, 80 and overAntiviral AgentsFemaleHospitalizationHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanMaleMiddle AgedTreatment OutcomeViral LoadZanamivirAntiviral AgentsZanamivirA/H1N1pdm09hospitalizedInfluenzaintravenous zanamivirpandemic influenzasafetyzanamivir

Identifiers

PMID23983212
PMCPMC4047294
OpenAlexW2103331025

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.