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Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial
CC. Butler, AW. van der Velden, E. Bongard, BR. Saville, J. Holmes, S. Coenen, J. Cook, NA. Francis, RJ. Lewis, M. Godycki-Cwirko, C. Llor, S. Chlabicz, C. Lionis, B. Seifert, PD. Sundvall, A. Colliers, R. Aabenhus, L. Bjerrum, N. Jonassen...
Language English Country Great Britain
Document type Adaptive Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Pragmatic Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Antiviral Agents administration & dosage therapeutic use MeSH
- Time Factors MeSH
- Influenza, Human therapy MeSH
- Child MeSH
- Adult MeSH
- Infant MeSH
- Combined Modality Therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Oseltamivir administration & dosage therapeutic use MeSH
- Child, Preschool MeSH
- Primary Health Care methods MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Child MeSH
- Adult MeSH
- Infant MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Child, Preschool MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Adaptive Clinical Trial MeSH
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Pragmatic Clinical Trial MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
BACKGROUND: Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups. METHODS: We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921. FINDINGS: Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group. INTERPRETATION: Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner. FUNDING: European Commission's Seventh Framework Programme.
Berry Consultants Austin Texas
Berry Consultants Austin TX USA
Clinic of Social and Family Medicine Faculty of Medicine University of Crete Crete Greece
College of Medicine University of Central Florida Orlando FL USA
David Geffen School of Medicine at UCLA Los Angeles CA USA
Department of Biostatistics Vanderbilt University School of Medicine Nashville Tennessee USA
Department of Family Medicine Medical University of Bialystok Bialystok Poland
Department of General Practice 1st Faculty of Medicine Charles University Prague Czech Republic
Department of Medical Microbiology Amsterdam UMC University of Amsterdam Netherlands
Department of Primary Care Health Services University of Oxford Oxford UK
Drug Research Centre Balatonfüred Hungary
Harbor UCLA Medical Center Torrance CA USA
JSC Mano seimos gydytojas Klaipeda Lithuania
Laboratory of Clinical Microbiology Antwerp University Hospital Edegem Belgium
National Heart and Lung Institute Imperial College London London UK
Primary Care and Population Sciences University of Southampton Southampton UK
University Institute in Primary Care Research Jordi Gol Via Roma Health Centre Barcelona Spain
References provided by Crossref.org
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