EFFECT OF INTERFERON-GAMMA ON INFECTION-RELATED DEATH IN PATIENTS WITH SEVERE INJURIES - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To assess the efficacy of interferon gamma in reducing infe ction and death in patients sustaining severe injury. Design: Multicen ter, randomized, double-blind, placebo-controlled trial with observati on for 60 days and until discharge for patients with major infection o n day 60. Setting: Nine university-affiliated level 1 trauma centers. Patients: Four hundred sixteen patients with severe injuries, assessed by Injury Severity Score and degree of contamination. Intervention: R ecombinant human interferon gamma, 100 mu g, was administered subcutan eously once daily for 21 days (or until patient discharge if prior to 21 days) as an adjunct to standard antibiotic and supportive therapy. Main Outcome Measures: Incidence of major infection, death related to infection, and death. Results: Infection rates were similar in both tr eatment groups; however, patients treated with interferon gamma experi enced fewer deaths related to infection (seven [3%] vs 18 [9%]; P=.008 ) and fewer overall deaths (21 [10%] vs 30 [14%]; P=.17). While 12 ear ly deaths (days 1 through 7) occurred in each treatment group, late de ath occurred in 18 placebo-treated patients and nine in interferon gam ma-treated patients. The results were dominated by findings at one cen ter, which had the highest enrollment and higher infection and death r ates. Statistical analysis did not eliminate the possibility of an uni dentified imbalance between arms as an explanation for the results. Co nclusion: Further evaluation is required to determine the validity of the observed reduction in infection-related deaths in patients treated with interferon gamma.