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

NCT01293071 | Completed Phase 4 DMC

• 2 other identifiers: UMCU_SATURNWP22011-000405-42
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infections

Keywords

Antibiotic rotation; Cycling; Mixing; Gram-negative; EU; Multi center; Multi Centre; Cluster randomized trial; Cross over

Outcome Measures

Primary Outcomes (1)

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

  Monthly point-prevalence screening of all ICU patients

Secondary Outcomes (4)

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

  2011-2013

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

  2011-2013

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

  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.

  2011-2013

Study Arms (2)

Mixing arm

ACTIVE COMPARATOR

Antibiotic rotation, each consecutive initiated antibiotic treatment a different class (one of 3 classes: cephalosporins, piperacillin-tazobactam, carbapenems)

Other: Antibiotic rotation

Cycling

ACTIVE COMPARATOR

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

Interventions

Antibiotic rotation OTHER

Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.

Also known as: Any antibiotic from the local guidelines can be used.

Cycling; Mixing arm

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

• van Duijn PJ, Verbrugghe W, Jorens PG, Spohr F, Schedler D, Deja M, Rothbart A, Annane D, Lawrence C, Jereb M, Seme K, Sifrer F, Tomic V, Estevez F, Carneiro J, Harbarth S, Bonten MJM. The effects of antibiotic cycling and mixing on acquisition of antibiotic resistant bacteria in the ICU: A post-hoc individual patient analysis of a prospective cluster-randomized crossover study. PLoS One. 2022 May 3;17(5):e0265720. doi: 10.1371/journal.pone.0265720. eCollection 2022.

  PMID: 35503768 DERIVED

• van Duijn PJ, Verbrugghe W, Jorens PG, Spohr F, Schedler D, Deja M, Rothbart A, Annane D, Lawrence C, Nguyen Van JC, Misset B, Jereb M, Seme K, Sifrer F, Tomic V, Estevez F, Carneiro J, Harbarth S, Eijkemans MJC, Bonten M; SATURN consortium. The effects of antibiotic cycling and mixing on antibiotic resistance in intensive care units: a cluster-randomised crossover trial. Lancet Infect Dis. 2018 Apr;18(4):401-409. doi: 10.1016/S1473-3099(18)30056-2. Epub 2018 Jan 26.

  PMID: 29396000 DERIVED

• 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.

  PMID: 25011604 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Marc Bonten, MD PhD Professor

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

NL (1)