A Randomized Trial of Ceftriaxone Compared with Penicillin G for Severe Leptospirosis (ประสิทธิภาพของยาเศฟไทรอะโซนเปรียบเทียบกับยาเพนิศิลลินในการรักษาผู้ป่วยโรคเลปโตสไปโรสิสอาการรุนแรง)

The objective was to compare the clinical efficacy between ceftriaxone and sodium penicillin G for the treatment of severe leptospirosis. A prospective, open-label, randomized trial was conducted in the Khon Kaen hospital between July 2000 and December 2001. One hundred and seventy-three patients with severe leptospirosis were randomly assigned to be treated with either intravenous ceftriaxone, 1 gram daily for 7 days, or intravenous sodium penicillin G, 1.5 million unit every 6 hour for 7 days. There were 87 and 86 patients in each group, respectively. The primary outcome was the time to the resolution of fever. Survival analysis demonstrated that median duration of fever were identical in the two groups, 3 days for each group. Upper boundary of the 95% confidence interval (CI) of the relative difference in the time to resolution of fever was 0.2 day and log-rank test p-value was 0.42. Ten patients died from leptospirosis infection, 5 in each group. There were no statistical differences in the duration of organ dysfunctions, including renal failure (RR, 1.0; 95% CI, 0.7 to 1.4), elevated serum aspatate aminotransferase (> 100 IU/L) (RR, 1.3; 95% CI, 0.7 to 2.2), jaundice (RR, 1.3; 95% CI, 0.7 to 2.4), and thrombocytopenia (RR, 0.9; 95% CI, 0.7 to 1.3). In conclusion, intravenous ceftriaxone and intravenous sodium penicillin G were equally effective for the treatment of severe leptospirosis. Administration of ceftriaxone once daily for seven consecutivedays provides additional benefit over intravenous penicillin.