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

November 30, 2015 updated by: MJM Bonten, UMC Utrecht

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Any antibiotic from the local guidelines can be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens
Time Frame: Monthly point-prevalence screening of all ICU patients
Monthly point-prevalence screening of all ICU patients

Secondary Outcome Measures

Outcome Measure
Time Frame
AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients.
Time Frame: 2011-2013
2011-2013
ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days)
Time Frame: 2011-2013
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
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
2011-2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Marc Bonten, MD PhD Professor, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCU_SATURNWP2
  • 2011-000405-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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