Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation (SATURN)
This study is currently recruiting participants.
Verified December 2010 by UMC Utrecht
Sponsor:
UMC Utrecht
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
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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
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
| 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 Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013