期刊
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
卷 307, 期 22, 页码 2390-2399出版社
AMER MEDICAL ASSOC
DOI: 10.1001/jama.2012.5833
关键词
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资金
- Bayer HealthCare AG
- AstraZeneca GmbH
- Thermo Fisher Scientific
- Pfizer Deutschland GmbH
- Becton Dickinson and Company
- bioMerieux Deutschland GmbH
- SIRS-Lab GmbH
- Biosyn GmbH
- Roche Diagnostics
- Drager Medical GmbH
- Sysmex Europe
- Biotest Pharma
- Merck Sharpe and Dohme
- Pulsion Medical Systems
- Edwards Life Sciences
- Becton Dickinson Management GmbHCo KG
- Maquet Critical Care and Carefusion
- Johnson Johnson
- UpToDate GmbH
- sanofi-aventis GmbH
- Bayer HeathCare AG
- Fresenius Kabi
- Baxter Germany
- CLS Behring
- GlaxoSmithKline
- Abbott
- Aspect
- Baxter
- Care Fusion
- Deltex
- Fresenius
- Grunenthal
- Hutchinson
- Kohler Chemie
- Medizinische Congressorganisation Nurnberg AG
- Novartis
- Pajunk
- Pulsion
- Roche
- Sysmex
- Essex Pharma
- German Federal Ministry of Education and Research [01 KI 0106, 01 EO 1002]
- Cubist
- Hospira
- Brahms GmbH
- Bayer HealthCare
- AstraZeneca
- Astellas
- Pfizer
- Paul-Martini Clinical Sepsis Research Group
- Thuringian Ministry of Education, Science and Culture [PE 108-2]
- Thuringian Foundation for Technology, Innovation and Research
- Jena Center of Sepsis Control and Care
Context Early appropriate antimicrobial therapy leads to lower mortality rates associated with severe sepsis. The role of empirical combination therapy comprising at least 2 antibiotics of different mechanisms remains controversial. Objective To compare the effect of moxifloxacin and meropenem with the effect of meropenem alone on sepsis-related organ dysfunction. Design, Setting, and Patients A randomized, open-label, parallel-group trial of 600 patients who fulfilled criteria for severe sepsis or septic shock (n=298 for monotherapy and n=302 for combination therapy). The trial was performed at 44 intensive care units in Germany from October 16, 2007, to March 23, 2010. The number of evaluable patients was 273 in the monotherapy group and 278 in the combination therapy group. Interventions Intravenous meropenem (1 g every 8 hours) and moxifloxacin (400 mg every 24 hours) or meropenem alone. The intervention was recommended for 7 days and up to a maximum of 14 days after randomization or until discharge from the intensive care unit or death, whichever occurred first. Main Outcome Measure Degree of organ failure (mean of daily total Sequential Organ Failure Assessment [SOFA] scores over 14 days; score range: 0-24 points with higher scores indicating worse organ failure); secondary outcome: 28-day and 90-day all-cause mortality. Survivors were followed up for 90 days. Results Among 551 evaluable patients, there was no statistically significant difference in mean SOFA score between the meropenem and moxifloxacin group (8.3 points; 95% CI, 7.8-8.8 points) and the meropenem alone group (7.9 points; 95% CI, 7.5-8.4 points) (P=.36). The rates for 28-day and 90-day mortality also were not statistically significantly different. By day 28, there were 66 deaths (23.9%; 95% CI, 19.0%-29.4%) in the combination therapy group compared with 59 deaths (21.9%; 95% CI, 17.1%-27.4%) in the monotherapy group (P=.58). By day 90, there were 96 deaths (35.3%; 95% CI, 29.6%-41.3%) in the combination therapy group compared with 84 deaths (32.1%; 95% CI, 26.5%-38.1%) in the monotherapy group (P=.43). Conclusion Among adult patients with severe sepsis, treatment with combined meropenem and moxifloxacin compared with meropenem alone did not result in less organ failure.
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