Mar. 3, 2008 Using a blood test and a decision algorithm, rather than standard hospital protocols, to determine the appropriate length of antibiotic therapy in patients with severe sepsis or septic shock can reduce duration of treatments, shorten ICU stays, and lower hospital costs-- all without adverse effects on patients, according to new research.
"We have shown that it is possible to customize antibiotic treatment duration in patients with septicemia based on a reliable and robust blood test," says Jérôme Pugin, M.D., of the Intensive Care Unit at the University Hospital in Geneva, Switzerland.
The researchers randomized 79 patients to receive a treatment course of antibiotics either according standard treatment protocols administered by the treating physicians, or according to the decision algorithm based on measured blood levels of procalcitonin (PCT), a marker for severe bacterial infection in patients with suspected sepsis. For patients randomized to the PCT-based treatment there were predetermined "stopping rules" based on circulating PCT levels at which point investigators encouraged treating physicians to discontinue antibiotic therapy, although the treating physician retained the ultimate decision-making power.
In the analysis that included all 79 patients, the median treatment time for the PCT group was 3.5 fewer days than that of the control group, although the difference was not significant. However, once the investigators controlled for early drop-outs, previously undiagnosed infections, and patients whose physicians declined to stop antibiotic treatment when the algorithm would have dictated it, they found that patients treated by the PCT algorithm had a significantly shorter treatment time at 6 days, than patients treated according to standard protocols, who averaged 12.5 days on antibiotics.
"Our study is the first randomized clinical trial in which a surrogate biochemical parameter was used to reduce the duration of antibiotic therapy in a population of critically ill patients admitted to the ICU for severe sepsis and septic shock," wrote Dr. Pugin. "Despite the relatively short duration of treatment in bacteremic patients assigned to the PCT group, no case of recurrence of infection was observed in these patients."
Following the PCT algorithm had another benefit: patients randomized to the PCT treatment had significantly shorter stays in the ICU than control patients--an average of three days versus five.
Customizing treatment does more than simply save hospitals money and patients precious days in the ICU, says Dr. Pugin. Overuse of antibiotics can result in antibiotic resistance. "Given the diversity of the types of infections, bacterial strains and levels of host immune defense, every infected patient should benefit from a personalized treatment, and particularly, a personalized treatment duration," he said.
The investigators hope that customized treatments will continue to improve care for sepsis patients around the world. "We have now implemented this new algorithm based on procalcitonin guidance in our ICU for patients presenting with severe sepsis and septic shock, and are following the outcome of those patients," said Dr. Pugin. "Currently, three large multi-center trials are ongoing in France, Denmark and Germany, with a design similar to that of our study. Results from these studies will be important to determine whether such a protocol of procalcitonin guidance is definitely safe and can be generalized worldwide."
The findings appear in the first issue for March of the American Journal of Respiratory and Clinical Care Medicine, published by the American Thoracic Society.
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