PMID- 23983212
OWN - NLM
STAT- MEDLINE
DCOM- 20140414
LR  - 20211021
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 209
IP  - 4
DP  - 2014 Feb 15
TI  - Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized 
      adults with influenza: an open-label, multicenter, single-arm, phase II study.
PG  - 542-50
LID - 10.1093/infdis/jit467 [doi]
AB  - BACKGROUND: Intravenous zanamivir is a neuraminidase inhibitor suitable for 
      treatment of hospitalized patients with severe influenza. METHODS: Patients 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. RESULTS: One 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. CONCLUSIONS: Safety, pharmacokinetic and clinical outcome data support 
      further investigation of intravenous zanamivir. CLINICAL TRIALS REGISTRATION: 
      NCT01014988.
FAU - Marty, Francisco M
AU  - Marty FM
AD  - Division of Infectious Diseases, Brigham and Women's Hospital, Boston, 
      Massachusetts.
FAU - Man, Choy Y
AU  - Man CY
FAU - van der Horst, Charles
AU  - van der Horst C
FAU - Francois, Bruno
AU  - Francois B
FAU - Garot, Denis
AU  - Garot D
FAU - Manez, Rafael
AU  - Manez R
FAU - Thamlikitkul, Visanu
AU  - Thamlikitkul V
FAU - Lorente, Jose A
AU  - Lorente JA
FAU - Alvarez-Lerma, Francisco
AU  - Alvarez-Lerma F
FAU - Brealey, David
AU  - Brealey D
FAU - Zhao, Henry H
AU  - Zhao HH
FAU - Weller, Steve
AU  - Weller S
FAU - Yates, Phillip J
AU  - Yates PJ
FAU - Peppercorn, Amanda F
AU  - Peppercorn AF
LA  - eng
SI  - ClinicalTrials.gov/NCT01014988
GR  - P30 AI050410/AI/NIAID NIH HHS/United States
GR  - P30-AI50410-14/AI/NIAID NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20130827
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antiviral Agents)
RN  - L6O3XI777I (Zanamivir)
SB  - IM
MH  - Administration, Intravenous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/administration & dosage/*adverse effects/*pharmacokinetics
MH  - Female
MH  - Hospitalization
MH  - Humans
MH  - Influenza A Virus, H1N1 Subtype/isolation & purification
MH  - Influenza, Human/*drug therapy/virology
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Viral Load
MH  - Zanamivir/administration & dosage/*adverse effects/*pharmacokinetics
PMC - PMC4047294
OTO - NOTNLM
OT  - A/H1N1pdm09
OT  - Influenza
OT  - hospitalized
OT  - intravenous zanamivir
OT  - pandemic influenza
OT  - safety
OT  - zanamivir
EDAT- 2013/08/29 06:00
MHDA- 2014/04/15 06:00
PMCR- 2020/06/24
CRDT- 2013/08/29 06:00
PHST- 2013/08/29 06:00 [entrez]
PHST- 2013/08/29 06:00 [pubmed]
PHST- 2014/04/15 06:00 [medline]
PHST- 2020/06/24 00:00 [pmc-release]
AID - jit467 [pii]
AID - 10.1093/infdis/jit467 [doi]
PST - ppublish
SO  - J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 
      Aug 27.