Department of Public Health, Epidemiology, Biostatistics and Prevention Institute, WHO Collaborating Centre for Travellers' Health, University of Zurich, Zurich, Switzerland.
Division of Epidemiology, Human Genetics & Environmental Sciences and Center for Infectious Diseases, University of Texas School of Public Health, Houston, TX, USA.
J Travel Med. 2018 Jan 1;25(1). doi: 10.1093/jtm/tay116.
The novel oral antibiotic formulation Rifamycin SV-MMX®, with a targeted delivery to the distal small bowel and colon, was superior to placebo in treating travellers' diarrhea (TD) in a previous study. Thus, a study was designed to compare this poorly absorbed antibiotic with the systemic agent ciprofloxacin.
In a randomized double-blind phase 3 study (ERASE), the efficacy and safety of Rifamycin SV-MMX® 400 mg twice daily (RIF-MMX) was compared with ciprofloxacin 500 mg twice daily in the oral treatment of TD. Overall, 835 international visitors to India, Guatemala or Ecuador with acute TD were randomized to receive a 3-day treatment with RIF-MMX (n = 420) or ciprofloxacin (n = 415). Primary endpoint was time to last unformed stool (TLUS), after which clinical cure was declared. Stools samples for microbiological evaluation were collected at the baseline visit and the end of treatment visit.
Median TLUS in the RIF-MMX group was 42.8 h versus 36.8 h in the ciprofloxacin group indicating non-inferiority of RIF-MMX to ciprofloxacin (P = 0.0035). Secondary efficacy endpoint results including clinical cure rate, treatment failure rate, requirement of rescue therapy as well as microbiological eradication rate confirmed those of the primary analysis indicating equal efficacy for both compounds. While patients receiving ciprofloxacin showed a significant increase of Extended Spectrum Beta Lactamase Producing-Escherichia coli (ESBL-E. Coli) colonization rates after 3-days treatment (6.9%), rates did not increase in patients receiving RIF-MMX (-0.3%). Both drugs were well-tolerated and safe.
The novel multi-matrix formulation of the broad-spectrum, poorly absorbed antibiotic Rifamycin SV was found non-inferior to the systemic antibiotic ciprofloxacin in the oral treatment of non-dysenteric TD with the advantage of a lower risk of ESBL-E. Coli acquisition.
新型口服抗生素 Rifamycin SV-MMX®，靶向递送至远端小肠和结肠，在之前的研究中优于安慰剂治疗旅行者腹泻（TD）。因此，设计了一项研究来比较这种吸收不良的抗生素与全身药物环丙沙星。
在一项随机、双盲、3 期研究（ERASE）中，比较了 Rifamycin SV-MMX®400mg 每日 2 次（RIF-MMX）与环丙沙星 500mg 每日 2 次在急性 TD 的口服治疗中的疗效和安全性。共有 835 名前往印度、危地马拉或厄瓜多尔的国际游客患有急性 TD，随机接受 3 天治疗，分别接受 RIF-MMX（n=420）或环丙沙星（n=415）治疗。主要终点是末次不成形粪便时间（TLUS），此后宣布临床治愈。在基线就诊和治疗结束就诊时采集粪便样本进行微生物学评估。
RIF-MMX 组的中位数 TLUS 为 42.8 小时，而环丙沙星组为 36.8 小时，表明 RIF-MMX 与环丙沙星的非劣效性（P=0.0035）。次要疗效终点结果，包括临床治愈率、治疗失败率、需要救援治疗以及微生物学清除率，均证实了主要分析的结果，表明两种药物具有同等疗效。虽然接受环丙沙星治疗的患者在 3 天治疗后，产Extended Spectrum Beta Lactamase Producing-Escherichia coli（ESBL-E. Coli）定植率显著增加（6.9%），但接受 RIF-MMX 治疗的患者没有增加（-0.3%）。两种药物均耐受良好且安全。
新型广谱、吸收不良抗生素 Rifamycin SV 的多基质制剂在非痢疾性 TD 的口服治疗中被发现与全身抗生素环丙沙星非劣效，且具有较低的产 ESBL-E. Coli 风险。
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