Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation
NCT ID: NCT01293071
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10000 participants
INTERVENTIONAL
2011-01-31
2014-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Mixing arm
Antibiotic rotation, each consecutive initiated antibiotic treatment a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems)
Antibiotic rotation
Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.
Cycling
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.
Antibiotic rotation
Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.
Interventions
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Antibiotic rotation
Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The ICU can adhere to the selected antibiotics for empiric treatment of infections.
* There is an operational digital patient-information system, from which data can be extracted and delivered in a pre-defined format. Specifically an automated process for digital data-collection regarding microbiological culture-results (from swabs and bacteraemias), antibiotic prescription and patient demographics and illness severity-scores.
* Colonization with ESBL or resistance for any of the antibiotic groups is endemic, with proportions of ICU-acquired bacteraemias used as a proxy. Therefore, the investigators prefer proportions of AMRB infection in the period 2008-2009 to be: ESBL resistance among GNB 1 to 10% Piperacillin/Tazobactam among GNB 1 to10% Carbapenem resistance among Klebsiella Pneumoniae less than 5%
* Have the ability of at least one dedicated Infection Control HCW available for 0,2fte, for patient monitoring, compliance monitoring and instruction of HCWs regarding interventions. In the following this person will be called "Research-Nurse" or "RN".
* Can store screening-cultures at -70ºC
* Can facilitate transport through a UMCU courier.
* There is written approval for the study from the institution's IRB with a waiver for patient informed consent.
* A signature page is signed by the daily management of the candidate-ICU by both ICU physician and director and the ICU nursing-director and presented to the UMCU, indicating willingness to enroll the candidate-ICU in the study.
Exclusion Criteria
* Burn units; due to the specific nature of the care provided and the patients admitted.
* Cardiothoracic surgery units; because of the expected small number of patients admitted for three days or more.
* Paediatric and neonatal ICUs.
10 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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MJM Bonten
Prof.dr.
Principal Investigators
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Marc Bonten, MD PhD Professor
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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2011-000405-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UMCU_SATURNWP2
Identifier Type: -
Identifier Source: org_study_id