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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000405-42 | EudraCT Number |
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The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of antibiotic resistant Gram-negative colonisation.
Antibiotic rotation has been previously studied with varied results. The theory behind antibiotic rotation is that intermittently changing antibiotic classes will reduce the ecological selective pressure that drives the emergence of antibiotic resistance.
This study compares the effect of 2 types of antibiotic rotation on Gram-negative colonisation in the ICU and also compares both interventions with standard care.
The two interventions apply to the empiric treatment and are: 1) "fast" rotation, i.e. every other patient another class and 2) "slow" rotation, i.e. every other 1.5month another preferred class for empiric Gram-negative antibiotic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixing arm | Active Comparator | Antibiotic rotation, each consecutive initiated antibiotic treatment a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems) |
|
| Cycling | Active Comparator | Antibiotic rotation, every 1.5 month a different preferred antibiotic treatment from a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems) is used for empiric treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic rotation | Other | Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens | Monthly point-prevalence screening of all ICU patients |
| Measure | Description | Time Frame |
|---|---|---|
| AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients. | 2011-2013 | |
| ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days) |
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Inclusion Criteria:
Exclusion Criteria:
ICUs planning to introduce, during the SATURN trial period, any major diagnostic- or intervention program that will affect AMRB ecology*
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| Name | Affiliation | Role |
|---|---|---|
| Marc Bonten, MD PhD Professor | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35503768 | Derived | van Duijn PJ, Verbrugghe W, Jorens PG, Spohr F, Schedler D, Deja M, Rothbart A, Annane D, Lawrence C, Jereb M, Seme K, Sifrer F, Tomic V, Estevez F, Carneiro J, Harbarth S, Bonten MJM. The effects of antibiotic cycling and mixing on acquisition of antibiotic resistant bacteria in the ICU: A post-hoc individual patient analysis of a prospective cluster-randomized crossover study. PLoS One. 2022 May 3;17(5):e0265720. doi: 10.1371/journal.pone.0265720. eCollection 2022. | |
| 29396000 |
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| ID | Term |
|---|---|
| D007239 | Infections |
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|
| 2011-2013 |
| Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population. | 2011-2013 |
| Effectiveness of empirical treatment of ICU-acquired bacteraemia, expressed as proportion of bacteraemia for which appropriate antibiotics are administered within 24 hours with antibiotics that the specific pathogens is susceptible for. | 2011-2013 |
| Derived |
| van Duijn PJ, Verbrugghe W, Jorens PG, Spohr F, Schedler D, Deja M, Rothbart A, Annane D, Lawrence C, Nguyen Van JC, Misset B, Jereb M, Seme K, Sifrer F, Tomic V, Estevez F, Carneiro J, Harbarth S, Eijkemans MJC, Bonten M; SATURN consortium. The effects of antibiotic cycling and mixing on antibiotic resistance in intensive care units: a cluster-randomised crossover trial. Lancet Infect Dis. 2018 Apr;18(4):401-409. doi: 10.1016/S1473-3099(18)30056-2. Epub 2018 Jan 26. |
| 25011604 | Derived | van Duijn PJ, Bonten MJ. Antibiotic rotation strategies to reduce antimicrobial resistance in Gram-negative bacteria in European intensive care units: study protocol for a cluster-randomized crossover controlled trial. Trials. 2014 Jul 10;15:277. doi: 10.1186/1745-6215-15-277. |