A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumoniaReportar como inadecuado




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Critical Care

, 16:R218

First Online: 13 November 2012Received: 05 September 2012Revised: 28 September 2012Accepted: 09 November 2012

Abstract

IntroductionThe aim of this study was to compare a 7-day course of doripenem to a 10-day course of imipenem-cilastatin for ventilator-associated pneumonia VAP due to Gram-negative bacteria.

MethodsThis was a prospective, double-blinded, randomized trial comparing a fixed 7-day course of doripenem one gram as a four-hour infusion every eight hours with a fixed 10-day course of imipenem-cilastatin one gram as a one-hour infusion every eight hours April 2008 through June 2011.

ResultsThe study was stopped prematurely at the recommendation of the Independent Data Monitoring Committee that was blinded to treatment arm assignment and performed a scheduled review of data which showed signals that were close to the pre-specified stopping limits.
The final analyses included 274 randomized patients.
The clinical cure rate at the end of therapy EOT in the microbiological intent-to-treat MITT population was numerically lower for patients in the doripenem arm compared to the imipenem-cilastatin arm 45.6% versus 56.8%; 95% CI -26.3% to 3.8%.
Similarly, the clinical cure rate at EOT was numerically lower for patients with Pseudomonas aeruginosa VAP, the most common Gram-negative pathogen, in the doripenem arm compared to the imipenem-cilastatin arm 41.2% versus 60.0%; 95% CI -57.2 to 19.5.
All cause 28-day mortality in the MITT group was numerically greater for patients in the doripenem arm compared to the imipenem-cilastatin arm 21.5% versus 14.8%; 95% CI -5.0 to 18.5 and for patients with P.
aeruginosa VAP 35.3% versus 0.0%; 95% CI, 12.6 to 58.0.

ConclusionsAmong patients with microbiologically confirmed late-onset VAP, a fixed 7-day course of doripenem was found to have non-significant higher rates of clinical failure and mortality compared to a fixed 10-day course of imipenem-cilastatin.
Consideration should be given to treating patients with VAP for more than seven days to optimize clinical outcome.

Trial RegistrationClinicalTrials.gov: NCT00589693

AbbreviationsAEadverse event

APACHEAcute Physiology and Chronic Health Evaluation

BALbronchoalveolar lavage

CIconfidence interval

CPISclinical pulmonary infection score

ELFepithelial lining fluid

EMAEuropean Medicines Agency

EOTend of therapy

ESBLextended-spectrum beta-lactamase

FiO2fraction of inspired oxygen

GCPgood clinical practices

ICUintensive care unit

IDMCIndependent Data Monitoring Committee

ITTintent-to-treat

MDRmultidrug-resistant

MICminimum inhibitory concentration

MITTmicrobiological intent-to-treat

PaO2partial pressure of arterial oxygen

PDpharmacodynamic

PKpharmacokinetic

VAPventilator-associated pneumonia

Electronic supplementary materialThe online version of this article doi:10.1186-cc11862 contains supplementary material, which is available to authorized users.

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Fuente: https://link.springer.com/



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