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Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation (SATURN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293071
First Posted: February 10, 2011
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht
February 9, 2011
February 10, 2011
December 2, 2015
January 2011
January 2013   (Final data collection date for primary outcome measure)
Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens [ Time Frame: Monthly point-prevalence screening of all ICU patients ]
Same as current
Complete list of historical versions of study NCT01293071 on ClinicalTrials.gov Archive Site
  • AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients. [ Time Frame: 2011-2013 ]
  • ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days) [ Time Frame: 2011-2013 ]
  • Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population. [ Time Frame: 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. [ Time Frame: 2011-2013 ]
Same as current
Not Provided
Not Provided
 
Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation
The SATURN Consortium, "Impact of Specific Antibiotic Therapies on the Prevalence of hUman Host ResistaNt Bacteria". Workpackage 2: The SATURN ICU-trial.
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections
Other: Antibiotic rotation
Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.
Other Name: Any antibiotic from the local guidelines can be used.
  • Active Comparator: Mixing arm
    Antibiotic rotation, each consecutive initiated antibiotic treatment a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems)
    Intervention: Other: Antibiotic rotation
  • Active Comparator: 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.
    Intervention: Other: Antibiotic rotation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
January 2014
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • There are at least 8 beds, with an average bed-occupancy of 80%; all of which have capacity for mechanical ventilation.
  • 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:

ICUs planning to introduce, during the SATURN trial period, any major diagnostic- or intervention program that will affect AMRB ecology*

  • 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.
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01293071
UMCU_SATURNWP2
2011-000405-42 ( EudraCT Number )
Yes
Not Provided
Not Provided
MJM Bonten, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Marc Bonten, MD PhD Professor UMC Utrecht
UMC Utrecht
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP