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Nelson N H Teng - One of the best experts on this subject based on the ideXlab platform.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:Background. HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. Methods. To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A(in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. Results. Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and sho...
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND: HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS: To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS: Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS: HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
Elizabeth J Ziegler - One of the best experts on this subject based on the ideXlab platform.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:Background. HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. Methods. To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A(in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. Results. Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and sho...
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND: HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS: To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS: Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS: HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
Richard C Straube - One of the best experts on this subject based on the ideXlab platform.
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treatment of septic shock with human monoclonal antibody ha 1a a randomized double blind placebo controlled trial chess trial study group
Annals of Internal Medicine, 1994Co-Authors: Richard V Mccloskey, Richard C Straube, Corazon Sanders, Susan M Smith, Craig R SmithAbstract:Objective To compare the effectiveness of 100 mg of HA-1A and placebo in reducing the 14-day all-cause mortality rate in patients with septic shock and Gram-Negative bacteremia in the Centocor: HA-1A Efficacy in Septic Shock (CHESS) trial, and to assess the safety of 100 mg of HA-1A given to patients with septic shock who did not have Gram-Negative bacteremia. Design Large, simple, group-sequential, randomized, double-blind, multicenter, placebo-controlled trial. Setting 603 investigators at 513 community and university-affiliated hospitals in the United States. Patients Within 6 hours before enrollment, the patients had been in shock with a systolic blood pressure of less than 90 mm Hg after adequate fluid challenge or had received vasopressors to maintain blood pressure. These episodes of shock began within 24 hours of enrollment. A presumptive clinical diagnosis of Gram-Negative Infection as the cause of the shock episode and a commitment from the patients' physicians to provide full supportive care were required. Measurements Blood cultures were obtained within 48 hours of enrollment, and death at day 14 after treatment was recorded. Adverse events occurring within 14 days after enrollment were also tabulated. Results 2199 patients were enrolled; 621 (28.2%) met all enrollment criteria, received HA-1A or placebo, and had confirmed Gram-Negative bacteremia. Mortality rates in this group were as follows: placebo, 32% (95 and HA-1A, 33% (109 of 328) (P = 0.864, Fisher exact test, two-tailed; 95% CI for the difference, -6.2% to 8.6%). Mortality rates in the patients without Gram-Negative bacteremia were as follows: placebo, 37% (292 of 793) and HA-1A, 41% (318 of 785) (P = 0.073, Fisher exact test, one-tailed; CI, -0.8% to 8.8%). Conclusions In this trial, HA-1A was not effective in reducing the 14-day mortality rate in patients with Gram-Negative bacteremia and septic shock. These data do not support using septic shock as an indication for HA-1A treatment. If HA-1A is effective in reducing the mortality rate in patients dying from endotoxemia, these patients must be identified using other treatment criteria.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:Background. HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. Methods. To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A(in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. Results. Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and sho...
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND: HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS: To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS: Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS: HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
R P Dellinger - One of the best experts on this subject based on the ideXlab platform.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:Background. HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. Methods. To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A(in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. Results. Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and sho...
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND: HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS: To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS: Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS: HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
Jerald C Sadoff - One of the best experts on this subject based on the ideXlab platform.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:Background. HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. Methods. To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A(in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. Results. Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and sho...
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
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treatment of Gram Negative bacteremia and septic shock with ha 1a human monoclonal antibody against endotoxin a randomized double blind placebo controlled trial the ha 1a sepsis study group
The New England Journal of Medicine, 1991Co-Authors: Elizabeth J Ziegler, Richard C Straube, Charles J Fisher, Charles L Sprung, Jerald C Sadoff, Garrett E Foulke, C H Wortel, M P Fink, R P Dellinger, Nelson N H TengAbstract:BACKGROUND: HA-1A is a human monoclonal IgM antibody that binds specifically to the lipid A domain of endotoxin and prevents death in laboratory animals with Gram-Negative bacteremia and endotoxemia. METHODS: To evaluate the efficacy and safety of HA-1A, we conducted a randomized, double-blind trial in patients with sepsis and a presumed diagnosis of Gram-Negative Infection. The patients received either a single 100-mg intravenous dose of HA-1A (in 3.5 g of albumin) or placebo (3.5 g of albumin). Other interventions, including the administration of antibiotics and fluids, were not affected by the study protocol. RESULTS: Of 543 patients with sepsis who were treated, 200 (37 percent) had Gram-Negative bacteremia as proved by blood culture. For the patients with Gram-Negative bacteremia followed to death or day 28, there were 45 deaths among the 92 recipients of placebo (49 percent) and 32 deaths among the 105 recipients of HA-1A (30 percent; P = 0.014). For the patients with Gram-Negative bacteremia and shock at entry, there were 27 deaths among the 47 recipients of placebo (57 percent) and 18 deaths among the 54 recipients of HA-1A (33 percent; P = 0.017). Analyses that stratified according to the severity of illness at entry showed improved survival with HA-1A treatment in both severely ill and less severely ill patients. Of the 196 patients with Gram-Negative bacteremia who were followed to hospital discharge or death, 45 of the 93 given placebo (48 percent) were discharged alive, as compared with 65 of the 103 treated with HA-1A (63 percent; P = 0.038). No benefit of treatment with HA-1A was demonstrated in the 343 patients with sepsis who did not prove to have Gram-Negative bacteremia. For all 543 patients with sepsis who were treated, the mortality rate was 43 percent among the recipients of placebo and 39 percent among those given HA-1A (P = 0.24). All patients tolerated HA-1A well, and no anti-HA-1A antibodies were detected. CONCLUSIONS: HA-1A is safe and effective for the treatment of patients with sepsis and Gram-Negative bacteremia.
