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- Title
Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial.
- Authors
Pinyo Rattanaumpawan; Peerawong Werarak; Anupop Jitmuang; Pattarachai Kiratisin; Visanu Thamlikitkul; Rattanaumpawan, Pinyo; Werarak, Peerawong; Jitmuang, Anupop; Kiratisin, Pattarachai; Thamlikitkul, Visanu
- Abstract
<bold>Background: </bold>Carbapenem antibiotics are considered the treatment of choice for serious extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria (GNB) infections. The study objectives were to evaluate efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae.<bold>Methods: </bold>We conducted a randomized controlled trial of adult patients with documented ESBL-producing Enterobacteriaceae infections who had received any group 2 carbapenem for less than 96 h. In the intervention group, the previously-prescribed group 2 carbapenem was de-escalated to ertapenem. In the control group, the group 2 carbapenem was continued.<bold>Results: </bold>During June 2011-December 2014, 32 patients were randomized to the de-escalation group and 34 to the control group. Most common sites of infection were urinary tract infection (42%). Characteristics of both groups were comparable. By using a 15% predefined margin, ertapenem was non-inferior to control group regarding the clinical cure rate (%Δ = 14.0 [95% confidence interval: -2.4 to 31.1]), the microbiological eradication rate (%Δ = 4.1 [-5.0 to 13.4]), and the superimposed infection rate (%Δ = -16.5 [-38.4 to 5.3]). Patients in the de-escalation group had a significantly lower 28-day mortality rate (9.4% vs. 29.4%; P = .05), a significantly shorter median length of stay (16.5 days [4.0-73.25] vs. 20.0 days [1.0-112.25]; P = .04), and a significantly lower defined daily dose of carbapenem use (12.9 ± 8.9 vs. 18.4 ± 12.6; P = .05).<bold>Conclusions: </bold>Ertapenem could be safely used as de-escalation therapy for ESBL-producing Enterobacteriaceae infections, once the susceptibility profiles are known. Future studies are needed to investigate ertapenem efficacy against ESBL-producing Enterobacteriaceae pneumonia to determine its applicability in life-threatening conditions.<bold>Trial Registration: </bold>ClinicalTrials.gov identifier: NCT01297842 . Registered on 14 February 2011. First patient enrolled on 27 June 2011.
- Subjects
ENTEROBACTERIACEAE diseases; CARBAPENEMS; ENTEROBACTERIACEAE; BETA lactamases; TREATMENT effectiveness; THERAPEUTICS; ANTIBIOTICS; BETA lactam antibiotics; COMPARATIVE studies; HYDROLASES; RESEARCH methodology; MEDICAL cooperation; RESEARCH; URINARY tract infections; EVALUATION research; RANDOMIZED controlled trials
- Publication
BMC Infectious Diseases, 2017, Vol 17, p1
- ISSN
1471-2334
- Publication type
journal article
- DOI
10.1186/s12879-017-2284-1