Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial
| العنوان: | Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial |
|---|---|
| المؤلفون: | Suveer Singh, Jennie Parker, Niall Anderson, Ashley Agus, Timothy S. Walsh, Gavin D. Perkins, Savita Gossain, Andrew Conway Morris, Lydia M Emerson, A. John Simpson, Thomas P Hellyer, Paul Dark, Tina Van Den Broeck, Bronagh Blackwood, Ronan McMullan, Daniel F. McAuley |
| المساهمون: | Conway Morris, Andrew [0000-0002-3211-3216], Apollo - University of Cambridge Repository |
| المصدر: | Trials Hellyer, T P, Anderson, N H, Parker, J, Dark, P, Van Den Broeck, T, Singh, S, McMullan, R, Agus, A M, Emerson, L M, Blackwood, B, Gossain, S, Walsh, T S, Perkins, G D, Conway Morris, A, McAuley, D F & Simpson, A J 2016, ' Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2) : Study protocol for a randomised controlled trial ', Trials, vol. 17, no. 1, 318, pp. 318 . https://doi.org/10.1186/s13063-016-1442-xTest, https://doi.org/10.1186/s13063-016-1442-xTest Hellyer, T P, Anderson, N H, Parker, J, Dark, P, Van Den Broeck, T, Singh, S, McMullan, R, Agus, A M, Emerson, L M, Blackwood, B, Gossain, S, Walsh, T S, Perkins, G D, Conway Morris, A, McAuley, D F & Simpson, A J 2016, ' Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2) : study protocol for a randomised controlled trial ', Trials, vol. 17, no. 1, pp. 318 . https://doi.org/10.1186/s13063-016-1442-xTest |
| بيانات النشر: | Springer Science and Business Media LLC, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Time Factors, Organ Dysfunction Scores, Interleukin-1beta, Antibiotics, Colony Count, Microbial, Medicine (miscellaneous), law.invention, Antimicrobial Stewardship, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, law, Antimicrobial stewardship, Pharmacology (medical), Hospital Mortality, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Antibiotic stewardship, Randomised controlled trial, Pneumonia, Ventilator-Associated, Intensive care unit, Anti-Bacterial Agents, 3. Good health, Research Design, Biomarker (medicine), Ventilator-acquired pneumonia, Erratum, Bronchoalveolar Lavage Fluid, medicine.medical_specialty, medicine.drug_class, Unnecessary Procedures, 1102 Cardiovascular Medicine And Haematology, 03 medical and health sciences, Predictive Value of Tests, General & Internal Medicine, Internal medicine, Pneumonia, Bacterial, medicine, Humans, Intensive care medicine, Bacteria, business.industry, Patient Selection, Interleukin-8, 1103 Clinical Sciences, Biomarker, Length of Stay, medicine.disease, Respiration, Artificial, United Kingdom, QR, respiratory tract diseases, Discontinuation, Pneumonia, 030228 respiratory system, business, Biomarkers, RC |
| الوصف: | Ventilator-acquired pneumonia (VAP) is a common reason for antimicrobial therapy in the intensive care unit (ICU). Biomarker-based diagnostics could improve antimicrobial stewardship through rapid exclusion of VAP. Bronchoalveloar lavage (BAL) fluid biomarkers have previously been shown to allow the exclusion of VAP with high confidence. This is a prospective, multi-centre, randomised, controlled trial to determine whether a rapid biomarker-based exclusion of VAP results in fewer antibiotics and improved antimicrobial management. Patients with clinically suspected VAP undergo BAL, and VAP is confirmed by growth of a potential pathogen at > 104 colony-forming units per millilitre (CFU/ml). Patients are randomised 1:1, to either a ‘biomarker-guided recommendation on antibiotics’ in which BAL fluid is tested for IL-1β and IL-8 in addition to routine microbiology testing, or to ‘routine use of antibiotics’ in which BAL undergoes routine microbiology testing only. Clinical teams are blinded to intervention until 6 hours after randomisation, when biomarker results are reported to the clinician. The primary outcome is a change in the frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL. Secondary outcome measures include antibiotic use at 14 and 28 days; ventilator-free days; 28-day mortality and ICU mortality; sequential organ failure assessment (SOFA) at days 3, 7 and 14; duration of stay in critical care and the hospital; antibiotic-associated infections; and antibiotic-resistant pathogen cultures up to hospital discharge, death or 56 days. A healthcare-resource-utilisation analysis will be calculated from the duration of critical care and hospital stay. In addition, safety data will be collected with respect to performing BAL. A sample size of 210 will be required to detect a clinically significant shift in the distribution of AFD towards more patients having fewer antibiotics and therefore more AFD. This trial will test whether a rapid biomarker-based exclusion of VAP results in rapid discontinuation of antibiotics and therefore improves antibiotic management in patients with suspected VAP. ISRCTN65937227 . Registered on 22 August 2013. ClinicalTrials.gov, NCT01972425 . Registered on 24 October 2013. |
| وصف الملف: | application/pdf |
| تدمد: | 1745-6215 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::63132763b2b644b00c5f0aa561b78b1eTest https://doi.org/10.1186/s13063-016-1442-xTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....63132763b2b644b00c5f0aa561b78b1e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
|---|