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JAMA. 2018 Nov 27;320(20):2087-2098. doi: 10.1001/jama.2018.13765.

Decontamination Strategies and Bloodstream Infections With Antibiotic-Resistant Microorganisms in Ventilated Patients: A Randomized Clinical Trial.

Author information

1
Intensive Care Center and Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
2
Medical Microbiology and Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
3
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, England.
4
Infectious Diseases-Internal Medicine, Hospital de Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain.
5
Department of Microbiology, Hospital de Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain.
6
Department of Intensive Care, Hospital de Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain.
7
Adult Critical Care, University Hospital of Wales, Cardiff, Wales.
8
Intensive Care, Ghent University Hospital, Ghent, Belgium.
9
Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium.
10
Department of Intensive Care Medicine, Clinique Saint Pierre, Ottignies-Louvain-la-Neuve, Belgium.
11
Microbiology Department, Clinique Saint Pierre, Ottignies-Louvain-la-Neuve, Belgium.
12
IntensiveCare Medicine, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.
13
Laboratory of Medical Microbiology, Vaccine, & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
14
Department of Intensive Care Medicine, CHU Liège, Liege, Belgium.
15
Clinical Microbiology, CHU Liège, Liege, Belgium.
16
Anesthesiology and Critical Care, AZ Sint Jan Bruges, Bruges, Belgium.
17
Microbiology Laboratory, Saint-Lucas Hospital Ghent, Ghent, Belgium.
18
Serviço de Medicina Intensiva, Centro Hospitalar de Trás-os-Montes os Montes e Alto Douro, Vila Real, Portugal.
19
Medical Intensive Care Unit, Hospital Clinic of Barcelona, Barcelona, Spain.
20
Microbiology Department, Hospital Clinic of Barcelona, Barcelona, Spain.
21
Laboratory for Respiratory Microbiology, University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
22
Intensive Care Unit, University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
23
Intensive Care Unit, Hospital Universitario La Fe, Valencia, Spain.
24
Intensive Care (UCIP), Hospital Santo Antonio-Centro Hospitalar do Porto (CHP), Porto, Portugal.
25
Microbiology Laboratory, Hospital Santo Antonio-Centro Hospitalar do Porto (CHP), Porto, Portugal.
26
Department of Microbiology, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.
27
Intensive Care Unit, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.
28
Department of Anesthesia and Intensive Care, Ospedale Infermi RIMINI-AUSL della Romagna, Rimini, Italy.
29
Medical Intensive Care and Infection Control Unit, CHU Henri Mondor & University Paris Est Créteil, Paris, France.

Abstract

Importance:

The effects of chlorhexidine (CHX) mouthwash, selective oropharyngeal decontamination (SOD), and selective digestive tract decontamination (SDD) on patient outcomes in ICUs with moderate to high levels of antibiotic resistance are unknown.

Objective:

To determine associations between CHX 2%, SOD, and SDD and the occurrence of ICU-acquired bloodstream infections with multidrug-resistant gram-negative bacteria (MDRGNB) and 28-day mortality in ICUs with moderate to high levels of antibiotic resistance.

Design, Setting, and Participants:

Randomized trial conducted from December 1, 2013, to May 31, 2017, in 13 European ICUs where at least 5% of bloodstream infections are caused by extended-spectrum β-lactamase-producing Enterobacteriaceae. Patients with anticipated mechanical ventilation of more than 24 hours were eligible. The final date of follow-up was September 20, 2017.

Interventions:

Standard care was daily CHX 2% body washings and a hand hygiene improvement program. Following a baseline period from 6 to 14 months, each ICU was assigned in random order to 3 separate 6-month intervention periods with either CHX 2% mouthwash, SOD (mouthpaste with colistin, tobramycin, and nystatin), or SDD (the same mouthpaste and gastrointestinal suspension with the same antibiotics), all applied 4 times daily.

Main Outcomes and Measures:

The occurrence of ICU-acquired bloodstream infection with MDRGNB (primary outcome) and 28-day mortality (secondary outcome) during each intervention period compared with the baseline period.

Results:

A total of 8665 patients (median age, 64.1 years; 5561 men [64.2%]) were included in the study (2251, 2108, 2224, and 2082 in the baseline, CHX, SOD, and SDD periods, respectively). ICU-acquired bloodstream infection with MDRGNB occurred among 144 patients (154 episodes) in 2.1%, 1.8%, 1.5%, and 1.2% of included patients during the baseline, CHX, SOD, and SDD periods, respectively. Absolute risk reductions were 0.3% (95% CI, -0.6% to 1.1%), 0.6% (95% CI, -0.2% to 1.4%), and 0.8% (95% CI, 0.1% to 1.6%) for CHX, SOD, and SDD, respectively, compared with baseline. Adjusted hazard ratios were 1.13 (95% CI, 0.68-1.88), 0.89 (95% CI, 0.55-1.45), and 0.70 (95% CI, 0.43-1.14) during the CHX, SOD, and SDD periods, respectively, vs baseline. Crude mortality risks on day 28 were 31.9%, 32.9%, 32.4%, and 34.1% during the baseline, CHX, SOD, and SDD periods, respectively. Adjusted odds ratios for 28-day mortality were 1.07 (95% CI, 0.86-1.32), 1.05 (95% CI, 0.85-1.29), and 1.03 (95% CI, 0.80-1.32) for CHX, SOD, and SDD, respectively, vs baseline.

Conclusions and Relevance:

Among patients receiving mechanical ventilation in ICUs with moderate to high antibiotic resistance prevalence, use of CHX mouthwash, SOD, or SDD was not associated with reductions in ICU-acquired bloodstream infections caused by MDRGNB compared with standard care.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02208154.

PMID:
30347072
PMCID:
PMC6583563
DOI:
10.1001/jama.2018.13765
[Indexed for MEDLINE]
Free PMC Article

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