The New England journal of medicine
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Randomized Controlled Trial Multicenter Study Clinical Trial
Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death.
In November 2001, the Food and Drug Administration (FDA) approved drotrecogin alfa (activated) (DrotAA) for adults who had severe sepsis and a high risk of death. The FDA required a study to evaluate the efficacy of DrotAA for adults who had severe sepsis and a low risk of death. ⋯ The absence of a beneficial treatment effect, coupled with an increased incidence of serious bleeding complications, indicates that DrotAA should not be used in patients with severe sepsis who are at low risk for death, such as those with single-organ failure or an APACHE II score less than 25.
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Multicenter Study Clinical Trial
Passive immunization during pregnancy for congenital cytomegalovirus infection.
Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy. ⋯ Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.