Treatment of severe infectious purpura in children with human plasma from donors immunized with Escherichia coli J5: a prospective double-blind study. J5 study Group.
To evaluate the efficacy of anti-J5 serum in the treatment of severe infectious purpura, 73 children were randomized to receive either anti-J5 (40) or control (33) plasma. Age, blood pressure, and biologic risk factors were similar in both groups. At admission, however, tumor necrosis factor serum concentrations were 974 +/- 173 pg/ml compared with 473 +/- 85 pg/ml (P = .023) and interleukin-6 serum concentrations were 129 +/- 45 compared with 19 +/- 5 ng/ml (P = .005) in the control and treated groups, respectively. The duration of shock and the occurrence of complications were similar in both groups. The mortality rate was 36% in the control group and 25% in the treated group (P = .317; odds ratio, 0.76; 95% confidence interval, 0.46-1.26). This trend disappeared after correction for unbalances in risk factors at randomization using a logistic regression model. These results suggest that anti-j5 plasma did not affect the course or mortality of severe infectious purpura in children.
D001424:Bacterial Infections / Q000150:complications / Q000628:therapy*; D001794:Blood Pressure; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004926:Escherichia coli / Q000276:immunology*; D005340:Fibrinogen / Q000032:analysis; D006192:Haemophilus Infections / Q000628:therapy; D006193:Haemophilus influenzae; D006801:Humans; D007116:Immunization, Passive; D015850:Interleukin-6 / Q000097:blood; D008589:Meningococcal Infections / Q000628:therapy; D011446:Prospective Studies; D011693:Purpura / Q000150:complications / Q000628:therapy*; D012044:Regression Analysis; D012307:Risk Factors; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis
D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D005340:Fibrinogen