Effective suppression of vancomycin-resistant Enterococcus species in asymptomatic gastrointestinal carriers by a novel glycolipodepsipeptide, ramoplanin

Citation
Mt. Wong et al., Effective suppression of vancomycin-resistant Enterococcus species in asymptomatic gastrointestinal carriers by a novel glycolipodepsipeptide, ramoplanin, CLIN INF D, 33(9), 2001, pp. 1476-1482
Citations number
38
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Clinical Immunolgy & Infectious Disease",Immunology
Journal title
CLINICAL INFECTIOUS DISEASES
ISSN journal
1058-4838 → ACNP
Volume
33
Issue
9
Year of publication
2001
Pages
1476 - 1482
Database
ISI
SICI code
1058-4838(20011101)33:9<1476:ESOVES>2.0.ZU;2-S
Abstract
Nosocomial bloodstream infections due to vancomycin-resistant enterococci ( VRE) are associated with increased morbidity rates, mortality rates, and ho spitalization costs. Gastrointestinal carriage of VRE is an important risk factor for subsequent infections. This 3-arm, phase II, double-blinded, ran domized, multicenter, placebo-controlled study evaluated the safety and eff icacy of oral ramoplanin (a novel, nonabsorbed glycolipodepsipeptide) versu s placebo for suppression of gastrointestinal VRE colonization. Sixty-eight patients who were colonized with VRE were enrolled and received 2 daily do ses of ramoplanin (100 mg or 400 mg) or placebo orally for 7 days. The prim ary end point was the proportion of persons per group from whom VRE were no t recovered (VRE-free) on days 7, 14, and 21 after screening. After treatme nt, VRE-free status was as follows: day 7, none of the 20 patients in the p lacebo group, and 17 of 21 (P<.001) and 18 of 20 (P<.001) in the 100-mg and 400-mg ramoplanin groups, respectively; on day 14, 2 of 20 patients in the placebo group, and 6 of 21 (P=.134) and 7 of 17 (P=.028), in the 100-mg an d 400-mg ramoplanin groups, respectively. By day 21, there were no differen ces between treatment groups. Adverse events were similar for all treatment groups. Ramoplanin was safe and effective in temporarily suppressing gastr ointestinal VRE carriage.