Decolonization of intestinal carriage of extended-spectrum Β-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: A randomized, double-blind, placebo-controlled trial

Objectives:Extended-spectrumb-lactamase-producing Enterobacteriaceae(ESBL-E) areanincreasingly frequent cause of infections in the community and the healthcare setting. In this study, we aimed to investigate whether intestinal carriage of ESBL-E can be eradicated.Methods: We conducted a double-blind, randomized, placebo-controlled, single-centre trial to assess the efficacy of an oral decolonization regimen on intestinal ESBL-E carriage in adult patients with an ESBL-E-positive rectal swab. Fifty-eight patients were allocated 1:1 to either placebo or colistin sulphate (50 mg 4×/day) and neomycin sulphate (250 mg 4×/day) for 10 days plus nitrofurantoin (100 mg 3×/day) for 5 days in the presence of ESBL-E bacteriuria. The primary outcome was detection of ESBL-E by rectal swab 28 ± 7 days after the end of treatment. Missing primary outcome data were imputed based on the last available observation. Additional cultures (rectal, inguinal and urine)were taken on day 6 of treatment and on days 1 and 7 post-treatment. The study protocol has been registered with ClinicalTrials.gov (NCT00826670). Results:Among54patients (27 ineach group) included in the primaryanalysis, therewasnostatistically significant difference between the groups with regard to the primary outcome [14/27 (52%) versus 10/27 (37%), P=40.27]. During treatment and shortly afterwards, there was significantly lower rectal ESBL-E carriage in the treatment group: 9/26 versus 19/22 on day 6 of treatment (P≤0.001) and 8/25 versus 20/26 on day 1 post-treatment (P=40.001). This effect had disappeared by day 7 post-treatment (18/27 versus 17/25, P=40.92). Liquid stools were more common in the treatment group (7/27 versus 2/29, P=40.05). Conclusions:The regimen used in this study temporarily suppressed ESBL-E carriage, but had no long-term effect.