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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01293071
First received: February 9, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of antibiotic resistant Gram-negative colonisation.


Condition Intervention Phase
Infections
Other: Antibiotic rotation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The SATURN Consortium, "Impact of Specific Antibiotic Therapies on the Prevalence of hUman Host ResistaNt Bacteria". Workpackage 2: The SATURN ICU-trial.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens [ Time Frame: Monthly point-prevalence screening of all ICU patients ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients. [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
  • ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days) [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
  • Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population. [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mixing arm
Antibiotic rotation, each consecutive initiated antibiotic treatment a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems)
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: 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293071

Contacts
Contact: Marc Bonten, MD PhD Professor 0031758888888 mbonten@umcutrecht.nl
Contact: Joppe van Duijn, MD MSc 0031758888888 pduijn3@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Marc Bonten, MD PhD Professor    00317588888    mbonten@umcutrecht.nl   
Principal Investigator: Marc Bonten, MD PhD Professor         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Marc Bonten, MD PhD Professor UMC Utrecht
  More Information

Additional Information:
No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MJM Bonten, MD, PhD, Prof of Molecular Epidemiology of Infectious Diseases, University Medical Center Utrecht, The Netherlands
ClinicalTrials.gov Identifier: NCT01293071     History of Changes
Other Study ID Numbers: UMCU_SATURNWP2, 2011-000405-42
Study First Received: February 9, 2011
Last Updated: February 9, 2011
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by UMC Utrecht:
Antibiotic rotation
Cycling
Mixing
Gram-negative
EU
Multi center
Multi Centre
Cluster randomized trial
Cross over

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014