HA-1A IN SEPTIC PATIENTS WITH ARDS - RESULTS FROM THE PIVOTAL TRIAL

Objective: To evaluate the effects of HA-1 A, a human monoclonal antie ndotoxin antibody, in septic patients with ARDS. Design: Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1 A in se ptic patients. Patients: 63 septic patients with ARDS at the time of s tudy entry. Intervention: A single intravenous injection of HA-1 A (10 0 mg) or placebo. Results: A quantitative radiographic score, the PaO2 /FIO2 ratio and an index of the severity of ARDS did not show a signif icant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did no t differ between the two groups. 15 of 30 HA-1 A treated patients (50% ) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. T he daily mortality was always lower in the HA-1 A group, but this diff erence was not statistically significant at 28 days. The 28-day surviv al curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression , a significant independent effect of HA-1 A treatment was detected up on the early survival rate at 7 days (p = 0.03) but not at 14 and 28 d ays. Conclusion: A single injection of HA-1A in septic patients with A RDS did not reverse acute respiratory failure or improve long-term sur vival.