SoM
Trial question
Is the isolation strategy of contact precautions in a multiple-bed room noninferior to a strategy of contact precautions in a single-bed room for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 463
463 patients (199 female, 264 male).
Inclusion criteria: adult patients with extended-spectrum β-lactamase-producing Enterobacteriaceae cultured from a routine clinical sample.
Key exclusion criteria: age < 18 years, a strict indication for barrier precautions in a single-bed room, no culture result reported within 7 days after the culture was obtained or before discharge, a wardmate known to be colonized or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram.
Interventions
N=188 a multiple-bed room isolation strategy (contact precautions in a multiple-bed room consisting of index patients plus wardmates).
N=275 a single-bed room isolation strategy (contact precautions in a single-bed room with index patients plus wardmates).
Primary outcome
Transmission of extended-spectrum β-lactamase-producing Enterobacteriaceae to at least one wardmate
7%
4%
7.0 %
5.3 %
3.5 %
1.8 %
0.0 %
A multiple-bed room isolation
strategy
A single-bed room isolation
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in transmission of extended-spectrum β-lactamase-producing Enterobacteriaceae to at least one wardmate (7% vs. 4%; ARD 3.4, 90% CI -0.3 to 7.1).
Secondary outcomes
No significant difference in rectal carriage of ESBL-producing Enterobacteriaceae in all wardmates (9% vs. 8%; RR 1.14, 95% CI 0.97 to 1.33).
No significant difference in length of hospital stay in wardmates (11 days vs. 11 days; RR 1.02, 95% CI 0.96 to 1.08).
No significant difference in death at 30 days in wardmates (4% vs. 4%; RR 1.14, 95% CI 0.9 to 1.43).
Conclusion
In adult patients with extended-spectrum β-lactamase-producing Enterobacteriaceae cultured from a routine clinical sample, a multiple-bed room isolation strategy was noninferior to a single-bed room isolation strategy with respect to transmission of extended-spectrum β-lactamase-producing Enterobacteriaceae to at least one wardmate.
Reference
Marjolein F Q Kluytmans-van den Bergh, Patricia C J Bruijning-Verhagen, Christina M J E Vandenbroucke-Grauls et al. Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study. Lancet Infect Dis. 2019 Oct;19(10):1069-1079.
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