alexa Course – Prevalence, Clinical Outcomes and Viral Shedding Patterns during Viral Respiratory Tract Infections in Intubated Intensive Care Unit–patients: Design and Protocol
ISSN: 2167-0870

Journal of Clinical Trials
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Protocol

Course – Prevalence, Clinical Outcomes and Viral Shedding Patterns during Viral Respiratory Tract Infections in Intubated Intensive Care Unit–patients: Design and Protocol

Frank van Someren Gréve1-3*, Koenraad F van der Sluijs2, Jan M Binnekade1, Annemarije Braber4, Olaf L Cremer5, Evert de Jonge6, Richard Molenkamp3, David SY Ong5, Sjoerd PH Rebers3, Angelique ME Spoelstra–de Man7, Peter E Spronk4, Kirsten D Verheul3, Monique C de Waard7, Rob BP de Wilde6, Tineke Winters1, Nicole P Juffermans1,2, Menno D de Jong3 and Marcus J Schultz1,2
1Department of Intensive Care, Academic Medical Center, Amsterdam, The Netherlands
2Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, Amsterdam, The Netherlands
3Department of Medical Microbiology, Academic Medical Center, Amsterdam, The Netherlands
4Department of Intensive Care, Gelre Hospitals, Apeldoorn, The Netherlands
5Department of Intensive Care, University Medical Center Utrecht, Utrecht, The Netherlands
6Department of Intensive Care, Leiden University Medical Center, Leiden, The Netherlands
7Department of Intensive Care, VU Medical Center, Amsterdam, The Netherlands
Corresponding Author : Frank van Someren Gréve, MD
Department of Intensive Care
Academic Medical Center, Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Tel: +312056328
E-mail: [email protected]
Received August 11, 2014; Accepted September 23, 2014; Published September 26, 2014
Citation: van Someren Gréve F, van der Sluijs KF, Binnekade JM, Braber A, Cremer OL, et al. (2014) Course – Prevalence, Clinical Outcomes and Viral Shedding Patterns during Viral Respiratory Tract Infections in Intubated Intensive Care Unit–patients: Design and Protocol. J Clin Trials 4:185. doi:10.4172/2167-0870.1000185
Copyright: © 2014 van Someren Gréve F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 

Abstract

Background: There is uncertainty about the prevalence of viral respiratory tract infections in intensive care unit (ICU) patients, and whether these infections contribute to disease severity and final outcome. Furthermore, the pattern of viral shedding during influenza infections in critically ill patients is largely unknown. Objectives: This study will assess prevalence of viral respiratory tract infections in intubated and ventilated ICU patients. Secondary objectives are to assess risk factors for and burden of viral respiratory tract infections, to describe the proportion of these infections missed in routine care, and to describe viral shedding patterns during influenza infection. Design: This is an investigator–initiated national multicenter prospective observational study conducted during one influenza season. Consecutive intubated and ventilated adult critically ill patients are included, regardless of admission diagnosis. Nasopharyngeal swabs and tracheobronchial aspirates are collected daily till patients are weaned of mechanical ventilation. Samples will be tested using multiplex real–time polymerase chain reaction (RT–PCR) for respiratory viruses. In influenza–positive patients, subsequent daily samples will be tested for influenza via RT–PCR until viral clearance. Influenza RT–PCR positive samples will be cultured and influenza subtyping will be performed. The primary endpoint is prevalence of viral respiratory tract infections in ICU patients. Discussion: COURSE will provide insight into the prevalence of, risk factors for, burden of and shedding patterns in viral respiratory tract infections in intubated and ventilated ICU patients during one winter season in the Netherlands. It is the largest prospective observational study thus far, with simultaneous sampling of both upper and lower respiratory tract of consecutive acutely admitted intubated and ventilated ICU patients, regardless of the admission diagnosis. Results of COURSE may guide future allocation and methods of viral diagnostic testing, quarantine practices, and duration of treatment with anti–viral drugs in ICU patients.

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