Trial reportBMC infectious diseases2017
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.
Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01297842 (An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Choice of therapeutic interventions and outcomes for the treatment of infections caused by multidrug-resistant gram-negative pathogens: a systematic review.Antimicrobial resistance and infection control · 2019Pooled it
- Prospective Observational Study of De-Escalation of Empirical Antibiotics in Fiji's National Hospital.Antibiotics (Basel, Switzerland) · 2025Article
- Antimicrobial Consumption and Resistance of Restricted Antibiotics in a Level III Government Hospital.Acta medica Philippina · 2024Article
- Thirty-Day Mortality Rates in Patients with Extended-Spectrum β-Lactamase-ProducingAntimicrobial agents and chemotherapy · 2022Article
- Implementation of Clinical Practice Guidelines for Empirical Antibiotic Therapy of Bacteremia, Urinary Tract Infection, and Pneumonia: A Multi-Center Quasi-Experimental Study.Antibiotics (Basel, Switzerland) · 2022Article
- Impact of Antibiotic Authorisation at Three Provincial Hospitals in Thailand: Results from a Quasi-Experimental Study.Antibiotics (Basel, Switzerland) · 2022Article
- An outbreak of ertapenem-resistant, carbapenemase-negative and porin-deficient ESBL-producingGerms · 2021Article
- Article
- Monitoring the antimicrobial susceptibility of Gram-negative organisms involved in intraabdominal and urinary tract infections recovered during the SMART study (Spain, 2016 and 2017).Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Article
- Activity of Ertapenem against Enterobacteriaceae in seven global regions-SMART 2012-2016.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Article
- Treatment of Infections Caused by Extended-Spectrum-Beta-Lactamase-, AmpC-, and Carbapenemase-Producing Enterobacteriaceae.Clinical microbiology reviews · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCarbapenem 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.
methodsWe 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.
resultsDuring 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).
conclusionsErtapenem 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.
trial registrationClinicalTrials.gov identifier: NCT01297842 . Registered on 14 February 2011. First patient enrolled on 27 June 2011.
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