CHICAGO (EGMN) – An investigational antibiotic was just as effective as vancomycin in curing Clostridium difficile infection, with a significantly lower recurrence rate, in a phase III trial.

Dr. Mark Miller reported at the annual Digestive Disease Week that a 10-day course of fidaxomicin achieved a global cure (symptomatic cure plus no recurrence) in 78% of patients who took it. In comparison, the global cure rate was 67% in patients who took vancomycin, he said.

Fidaxomicin is being developed by Optimer Pharmaceuticals Inc.; the company also sponsored the trial. It is a macrocytic antibiotic, which works by inhibiting bacterial RNA polymerase, according to information on the company Web site.

The trial included 629 patients (mean age 61 years) with C. difficile infections. They reported a mean of nine unformed bowel movements per day; 6% were inpatients, and 6% had failed a course of metronidazole.

Patients were randomized to 10 days of either fidaxomicin 200 mg twice a day, or vancomycin 125 mg 4 times per day. The primary end point was clinical cure, defined as resolution of symptoms and no need for additional therapy for 2 days after stopping the study drug. The secondary end points were recurrence and global cure.

The per-protocol analysis included 548 patients. Cure rates were not significantly different between the treatment groups, at 92% for fidaxomicin and 90% for vancomycin. However, recurrence rates were significantly lower in the fidaxomicin group (13% vs. 24%, respectively). Global cure rates were significantly higher in the fidaxomicin group (78% vs. 67%, respectively).

In a subgroup analysis, fidaxomicin was associated with lower recurrence rates than was vancomycin, regardless of the patient’s white blood cell count or fever. Recurrence rates were also lower with fidaxomicin regardless of the albumin level.

Also, the recurrence rate was significantly lower with fidaxomicin in patients with non–BI/NAP1/027 C. difficile strains (8% vs. 25%).

Dr. Miller said the safety and adverse events profiles were similar in the two groups, but he did not present specifics on adverse events. Nor were adverse events specified in the trial report on the Optimer Web site.

Dr. Miller is head of the division of infectious diseases at McGill University, Montreal. He did not disclose any financial relationship with Optimer or any financial interest in fidaxomicin.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

芝加哥(EGMN)——一个在III期试验研究中的抗生素在治疗艰难梭菌感染中与万古霉素同样有效，并且复发率显著降低。

 

Mark Miller医生在每年一度的“消化道疾病周”上报告说，10天的fidaxomicin疗程使78%的患者获得了全面治愈(症状痊愈并且无复发)， 而在使用万古霉素的患者中全面治愈率为67%。

 

Fidaxomicin由Optimer制药公司生产；这家公司也资助了该研究。据该公司网站上称，该药品是大环内酯类抗生素，作用机理是阻断细菌的RNA聚合酶。

 

该实验包括629名患有艰难梭菌感染的患者(平均年龄61岁)。报告说平均每天有9次未成型的肠蠕动；6%为住院病人， 6%经甲硝唑治疗失败。

 

病人被随机分成两组，接受为期10天fidaxomicin 200 mg每天2次或万古霉素125 mg每天4次的治疗。主要的结束点为临床治愈， 定义为症状缓解， 停药后无需附加治疗。次要结束点为复发及全面治愈。

 

原始记录分析包括了548名患者。fidaxomicin治愈率为92%，而万古霉素为90%，在两组间无显著差异。然而， 复发率在fidaxomicin组显著降低(依次为13%和24%)。 全面治愈率在fidaxomicin组明显较高(依次为78%和 67%)。

 

在分组分析中，fidaxomicin较万古霉素有更低的复发率， 这一结果与患者的白细胞计数、发热无关，与白蛋白水平也无关。

 

并且，在fidaxomicin组中，带有非BI/NAP1/027艰难梭菌菌株的复发率显著降低(8%及25%)。

 

Miller医生称安全性和不良反应在两组中相似，但他没有对不良反应做具体报告，在Optimer的网站上也没有关于不良反应的具体说明。

 

Miller医生是蒙特利尔McGill大学传染病系的主任。他没有提到与Optimer公司的财务关联或与fidaxomicin相关的经济利益。

 

 

据一个III期临床试验称，10天的fidaxomicin疗程使78%的患者获得了全面治愈。在使用万古霉素的患者中全面治愈率为67% (照片提供：美国 CDC/Gilda Jones医生) 。