Antivirals for influenza-like illness? A randomized Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4E): The ALIC4E Protocol
| Autor: | Frederico Martinón-Torres, Jane Holmes, Maciek Godycki-Cwirko, Dionyssios Varthalis, Theo J M Verheij, Ruta Radzeviciene-Jurgute, Emily Bongard, Pia Touboul, Alike W van der Velden, Philippe Beutels, Margareta Ieven, Ana Moragas, Johanna Cook, Antoni Torres, An De Sutter, Nick A Francis, Pär-Daniel Sundvall, Paul Little, Herman Goossens, Morten Lindbæk, Annelies Colliers, Rune Aabenhus, József Pauer, Muireann De Paor, Dominik Glinz, Christopher C Butler, Curt Brugman, Sławomir Chlabicz, Menno de Jong, Melanie J. Davies, Ben Saville, Samuel Coenen, Markéta Pfeiferová |
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| Přispěvatelé: | Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Medical Microbiology and Infection Prevention, AII - Infectious diseases |
| Rok vydání: | 2018 |
| Předmět: |
Male
Time Factors Cost effectiveness Cost-Benefit Analysis 030204 cardiovascular system & hematology law.invention chemistry.chemical_compound ALIC4 E protocol 0302 clinical medicine Randomized controlled trial law Health care Activities of Daily Living Protocol Medicine Multicenter Studies as Topic 030212 general & internal medicine Medicaments antivírics adaptive clinical trial Headache General Medicine Antivirals 3. Good health Hospitalization Europe Female Symptom Assessment General practice / Family practice influenza Pandemic influenza Retroviral medicine.medical_specialty Oseltamivir Prescription Drugs Fever oseltamivir Nonprescription Drugs Antiviral Agents Grip 03 medical and health sciences primary healthcare Influenza Human Pragmatic Clinical Trials as Topic Humans Influenza-like illness Adaptive clinical trial business.industry cost-benefit analysis Myalgia Pneumonia medicine.disease Comorbidity Influenza Clinical trial Self Care Antiviral agents chemistry Emergency medicine Human medicine business |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela instname BMJ open BMJ open, 8(7). BMJ Publishing Group BMJ Open Recercat. Dipósit de la Recerca de Catalunya Bongard, E, van der Velden, A W, Cook, J, Saville, B, Beutels, P, Aabenhus, R M, Brugman, C, Chlabicz, S, Coenen, S, Colliers, A, Davies, M, De Paor, M, De Sutter, A, Francis, N A, Glinz, D, Godycki-cwirko, M, Goossens, H, Holmes, J, Ieven, M, de Jong, M, Lindbaek, M, Little, P, Martinon-Torres, F, Moragas, A, Pauer, J, Pfeiferova, M, Radzeviciene-Jurgute, R, Sundvall, P-D, Torres, A, Touboul, P, Varthalis, D, Verheij, T & Butler, C C 2018, ' Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC 4 E) : the ALIC 4 E protocol ', BMJ Open, vol. 8, no. 7, e021032 . https://doi.org/10.1136/bmjopen-2017-021032 |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2017-021032 |
| Popis: | IntroductionEffective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies.Methods and analysisAntivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48–72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms.Ethics and disseminationResearch ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations.Trial registration numberISRCTN27908921; Pre-results. |
| Databáze: | OpenAIRE |
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