జర్నల్ ఆఫ్ క్లినికల్ ట్రయల్స్
అందరికి ప్రవేశం

నైరూప్య

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 Gréve, Koenraad F van der Sluijs, Jan M Binnekade, Annemarije Braber, Olaf L Cremer, Evert de Jonge, Richard Molenkamp, David SY Ong, Sjoerd PH Rebers, Angelique ME Spoelstra–de Man, Peter E Spronk, Kirsten D Verheul, Monique C de Waard, Rob BP de Wilde, Tineke Winters, Nicole P Juffermans, Menno D de Jong and

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.