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NCT Number: NCT01293071

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

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

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Key information

Conditions

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibiotic rotation

Other

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.

Primary outcomes

  1. Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens

    Time frame: Monthly point-prevalence screening of all ICU patients

Secondary outcomes

  1. AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients.

    Time frame: 2011-2013

  2. ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days)

    Time frame: 2011-2013

  3. Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population.

    Time frame: 2011-2013

  4. 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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

The SATURN Consortium, "Impact of Specific Antibiotic Therapies on the Prevalence of hUman Host ResistaNt Bacteria". Workpackage 2: The SATURN ICU-trial.

Acronym: SATURN

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 10, 2011
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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