Abstract
BackgroundIntensive care units (ICU) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria (ARGNB) because of high rates of antibiotic usage, rapid patient turnover, immunological susceptibility of acutely ill patients, and frequent contact between healthcare workers and patients, facilitating cross-transmission.Antibiotic stewardship programs are considered important to reduce antibiotic resistance, but the effectiveness of strategies such as, for instance, antibiotic rotation, have not been determined rigorously. Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs. In this cluster-randomized, crossover trial the effects of two antibiotic rotation strategies, antibiotic mixing and cycling, on the prevalence of ARGNB in ICUs are determined. Antibiotic mixing aims to create maximum antibiotic heterogeneity, and cycling aims to create maximum antibiotic homogeneity during consecutive periods.Methods/DesignThis is an open cluster-randomized crossover study of mixing and cycling of antibiotics in eight ICUs in five European countries. During cycling (9 months) third- or fourth-generation cephalosporins, piperacillin-tazobactam and carbapenems will be rotated during consecutive 6-week periods as the primary empiric treatment in patients suspected of infection caused by Gram-negative bacteria. During mixing (9 months), the same antibiotics will be rotated for each consecutive antibiotic course. Both intervention periods will be preceded by a baseline period of 4 months. ICUs will be randomized to consecutively implement either the mixing and then cycling strategy, or vice versa. The primary outcome is the ICU prevalence of ARGNB, determined through monthly point-prevalence screening of oropharynx and perineum. Secondary outcomes are rates of acquisition of ARGNB, bacteremia and appropriateness of therapy, length of stay in the ICU and ICU mortality. Results will be adjusted for intracluster correlation, and patient- and ICU-level variables of case-mix and infection-prevention measures using advanced regression modeling.DiscussionThis trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs.Trial registrationClinicalTrials.gov NCT01293071 December 2010.
Highlights
Intensive care units (ICU) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria (ARGNB) because of high rates of antibiotic usage, rapid patient turnover, immunological susceptibility of acutely ill patients, and frequent contact between healthcare workers and patients, facilitating cross-transmission
This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs
Infections caused by Gram-negative bacteria frequently complicate treatment of critically ill patients in the intensive care unit (ICU)
Summary
Infections caused by Gram-negative bacteria frequently complicate treatment of critically ill patients in the intensive care unit (ICU). The treatment is changed with every new antibiotic course, and in cycling, empiric antibiotics change per time block (weeks or months) These interventions have been evaluated in ICUs, and in neonatal-, pediatric-, oncology- and cardiothoracic-surgery departments [2-23]. Study design, data collection and statistical analyses did not always take into account clustering of antibiotic resistance within ICUs, confounding by antibiotic use and changes in case-mix or infection prevention measures [24] This multicenter cluster randomized crossover trial was designed to determine the effects of mixing and cycling of antibiotics in eight European ICUs, incorporating the most relevant confounders and adjusting for clustering of results in the analysis. Study objectives The primary objective of this trial is to compare the effects of a strategy of antibiotic mixing (rotation of empirical antibiotic treatment per individual patient) to a strategy of antibiotic cycling (preferred empirical antibiotic treatment changes every 6 weeks) on the mean unit-wide prevalence of antibiotic-resistant Gram-negative bacteria (ARGNB). The SATURN ICU trial was registered in the ClinicalTrials.gov (NCT01293071)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
