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Intravenous Zanamivir in Hospitalized Patients With Influenza
- Source :
- Pediatrics. 140(5)
- Publication Year :
- 2017
-
Abstract
- BACKGROUND: Children with severe influenza infection may require parenteral therapy if oral or inhaled therapies are ineffective or cannot be administered. Results from a study investigating intravenous (IV) zanamivir for the treatment of hospitalized infants and children with influenza are presented. METHODS: This phase II, open-label, multicenter, single-arm study assessed the safety of investigational IV zanamivir in hospitalized children with influenza. Safety outcomes included treatment-emergent adverse events (TEAEs), clinical laboratory measurements, and vital signs. Clinical outcomes, pharmacokinetics, and virologic efficacy data were collected as key secondary outcomes. RESULTS: In total, 71 children received treatment with investigational IV zanamivir (exposure comparable to 600 mg twice daily in adults). TEAEs and serious TEAEs (STEAEs) were reported in 51 (72%) and 15 (21%) patients, respectively. The mortality rate was 7%, and median durations of hospital and ICU stays were 6 and 7.5 days, respectively. No STEAEs or deaths were considered related to IV zanamivir treatment, and no patterns of TEAEs, laboratory abnormalities, or vital signs were observed. The mean zanamivir exposures from 34 patients with normal renal function who received 12 mg/kg, 14 mg/kg, or 600 mg of IV zanamivir ranged from 64.5 to 110 hour·µg/mL. The median change from baseline in the viral load was −1.81 log10 copies per mL after 2 days of treatment. CONCLUSIONS: The safety profile of IV zanamivir was favorable, with no drug-related STEAEs reported. The majority of children experienced virologic response and clinical improvement during the treatment course. Systemic zanamivir exposures in children were consistent with adults.
- Subjects :
- 0301 basic medicine
Male
medicine.medical_specialty
Neutropenia
Adolescent
030106 microbiology
Vital signs
Antiviral Agents
03 medical and health sciences
Zanamivir
Pharmacokinetics
Internal medicine
Influenza, Human
medicine
Humans
Adverse effect
Child
Infusions, Intravenous
business.industry
Mortality rate
Infant
Viral Load
medicine.disease
Surgery
Clinical trial
Hospitalization
Child, Preschool
Pediatrics, Perinatology and Child Health
Female
business
Viral load
medicine.drug
Subjects
Details
- ISSN :
- 10984275
- Volume :
- 140
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Pediatrics
- Accession number :
- edsair.doi.dedup.....cd65bb9fb3bd75ae5f04fb80df013e9d