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 infection and death in patients sustaining severe injury.

DESIGN

Multicenter, randomized, double-blind, placebo-controlled trial with observation for 60 days and until discharge for patients with major infection on 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

Recombinant human interferon gamma, 100 micrograms, was administered subcutaneously 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 treatment groups; however, patients treated with interferon gamma experienced 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 early deaths (days 1 through 7) occurred in each treatment group, late death occurred in 18 placebo-treated patients and nine in interferon gamma-treated patients. The results were dominated by findings at one center, which had the highest enrollment and higher infection and death rates. Statistical analysis did not eliminate the possibility of an unidentified imbalance between arms as an explanation for the results.

CONCLUSION

Further evaluation is required to determine the validity of the observed reduction in infection-related deaths in patients treated with interferon gamma.