Rationale and design of ASPIRE-ICU: a prospective cohort study on the incidence and predictors of Staphylococcus aureus and Pseudomonas aeruginosa pneumonia in the ICU

The epidemiology of ICU pneumonia caused by Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa) is not fully described, but is urgently needed to support the development of effective interventions. The objective of this study is to estimate the incidence of S. aureus and P....

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Published in:	BMC infectious diseases Vol. 17; no. 1; p. 643
Main Authors:	Paling, Fleur P, Troeman, Darren P R, Wolkewitz, Martin, Kalyani, Rubana, Prins, Daniël R, Weber, Susanne, Lammens, Christine, Timbermont, Leen, Goossens, Herman, Malhotra-Kumar, Surbhi, Sifakis, Frangiscos, Bonten, Marc J M, Kluytmans, Jan A J W
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 25-09-2017 BioMed Central BMC
Subjects:	Cohort analysis Complications and side effects Epidemiology ICU pneumonia Incidence Infectious diseases Mathematical models Mechanical ventilation P. aeruginosa Pathogens Pneumonia Pseudomonas Pseudomonas aeruginosa Pseudomonas aeruginosa infections Risk analysis Risk factors S. aureus Staphylococcus aureus Staphylococcus aureus infections Staphylococcus infections Studies Study Protocol Surveillance Vap Ventilators S. aureus ICU pneumonia Vap P. aeruginosa
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Summary:	The epidemiology of ICU pneumonia caused by Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa) is not fully described, but is urgently needed to support the development of effective interventions. The objective of this study is to estimate the incidence of S. aureus and P. aeruginosa ICU pneumonia and to assess its association with patient-related and contextual risk factors. ASPIRE-ICU is a prospective, observational, multi-center cohort study nested within routine surveillance among ICU patients in Europe describing the occurrence of S. aureus and P. aeruginosa ICU pneumonia. Two thousand (2000) study cohort subjects will be enrolled (50% S. aureus colonized) in which specimens and data will be collected. Study cohort subjects will be enrolled from a larger surveillance population, in which basic surveillance data is captured. The primary outcomes are the incidence of S. aureus ICU acquired pneumonia and the incidence of P. aeruginosa ICU acquired pneumonia through ICU stay. The analysis will include advanced survival techniques (competing risks and multistate models) for each event separately as well as for the sub-distribution of ICU pneumonia to determine independent association of outcomes with risk factors.. A risk prediction model will be developed to quantify the risk for acquiring S. aureus or P. aeruginosa ICU pneumonia during ICU stay by using a composite score of independent risk factors. The diagnosis of pathogen-specific ICU pneumonia is difficult, however, the criteria used in this study are objective and comparable to those in the literature. This study is registered on clinicaltrials.gov under identifier NCT02413242 .
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1471-2334 1471-2334
DOI:	10.1186/s12879-017-2739-4