Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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Randomized Controlled Trial Clinical Trial
Drotrecogin alfa (activated) treatment of older patients with severe sepsis.
The incidence of severe sepsis increases dramatically with advanced age, with a mortality rate that approaches 50%. The main purpose of this investigation was to determine both short- and long-term survival outcomes among 386 patients aged >or=75 years who were enrolled in the Protein C Worldwide Evaluation of Severe Sepsis (PROWESS) trial. Subjects who were treated with drotrecogin alfa (activated; DAA) had absolute risk reductions in 28-day and in-hospital mortality of 15.5% and 15.6%, respectively (P=.002 for both), compared with placebo recipients. ⋯ The incidences of serious adverse bleeding during the 28-day study period in the DAA and placebo groups were 3.9% and 2.2%, respectively (P=.34). There was no interaction between age and bleeding rates (P=.97). In conclusion, older patients with severe sepsis have higher short- and long-term survival rates when treated with DAA than when treated with placebo but an increased risk of serious bleeding that is not aged related.
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Guillain-Barré syndrome (GBS) is a rare but serious complication of infectious intestinal disease due to Campylobacter jejuni. To date, estimates of the burden of C. jejuni-associated GBS have been based on limited data regarding the proportion of GBS attributable to this pathogen. In this paper, we combine data obtained from Sweden and a large study of infectious intestinal disease with routine and surveillance data from England to estimate the number and proportion of GBS cases attributable to C. jejuni. We estimate that, between 1 April 2000 and 31 March 2001, symptomatic C. jejuni infection was responsible for 157 cases of GBS, constituting approximately 15% of all GBS cases in England.
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Controversy surrounds the role of central venous catheters (CVCs) impregnated with antimicrobial agents in the prevention of catheter-related bloodstream infection (CRBSI). We reviewed the current literature to evaluate the efficacy of antimicrobial-impregnated CVCs for preventing CRBSI. Eleven randomized studies published in article form were identified that included a control group that received nonimpregnated CVCs. ⋯ Review of these 11 trials revealed several methodological flaws, including inconsistent definitions of CRBSI, failure to account for confounding variables, suboptimal statistical and epidemiological methods, and rare use of clinically relevant end points. This review also failed to demonstrate any significant clinical benefit associated with the use of antimicrobial-impregnated CVCs for the purpose of reducing CRBSI or improving patient outcomes. More rigorous studies are required to support or refute the hypothesis that antimicrobial-impregnated CVCs reduce the rate of or prevent CRBSI.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Systemic host responses in severe sepsis analyzed by causative microorganism and treatment effects of drotrecogin alfa (activated).
Clinical trials with novel therapeutic agents for severe sepsis have suggested that patients might respond differently depending on causative microorganism. Data from a large, placebo-controlled trial of recombinant human drotrecogin alfa (activated) (DrotAA) were analyzed by type of causative microorganism for treatment-associated differences in mortality, coagulopathy, and inflammatory response. ⋯ Levels of coagulation and inflammation biomarkers varied with different pathogens at study entry. Results demonstrate that DrotAA, administered as an adjunct to standard anti-infective therapy, can improve the rate of survival for patients who develop severe sepsis regardless of causative microorganism.