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%), P¼0.27].
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
(P¼0.001). This effect had disappeared by day 7 post-treatment (18/27 versus 17/25, P¼0.92). Liquid stools
were more common in the treatment group (7/27 versus 2/29, P¼0.05).
Conclusions: The regimen used in this study temporarily suppressed ESBL-E carriage, but had no long-term effect.