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

Infections Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293071
• Other study ID #: UMCU_SATURNWP2
• Secondary ID: 2011-000405-42
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2011
• Last updated: November 30, 2015
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections

Intervention

Other:
• Antibiotic rotation
Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens		Monthly point-prevalence screening of all ICU patients	No
Secondary	AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients.		2011-2013	No
Secondary	ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days)		2011-2013	No
Secondary	Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population.		2011-2013	No
Secondary	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.		2011-2013	No

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