Colonisation was assessed for each body site specimen, and yeasts were identified. Fungal colonisation was defined as the presence of thing the same yeast on one or more of the six distinct body sites tested (blood sample excepted). The CI was calculated for each multiple-site testing as the ratio between the number of distinct body sites colonised by Candida species (except blood) and the total number of sites tested. The CCI was calculated for each time point as the product of the CI multiplied by the ratio of the number of distinct nonblood body sites showing heavy growth to the total of body sites growing Candida species. Fungal infection was defined as either the presence of candidaemia or the identification of Candida species in a normally sterile body site, associated with severe sepsis and negative tests for bacteria.

During the study period, adverse events related to the study drug were monitored (that is, diarrhoea, nausea, vomiting, intestinal pain, urticarial skin reactions).Outcome measures and statistical analysisContinuous variables are expressed as the mean �� standard deviation or median (interquartile range). Categorical variables were compared by chi-square test or Fisher’s exact test. Student’s t test was used to compare normally distributed continuous variables, and the Mann-Whitney U test was used to analyse variables not normally distributed. All P values were two-tailed. Statistical significance was set at P �� 0.05. For an estimated rate of fungal colonisation reaching approximately 60% in ICU patients, 49 patients per group had to be enrolled in the study to show a 50% reduction in fungal colonisation, with an �� error of 5% and a �� error of 20%.

ResultsOf 260 patients assessed for eligibility, 128 were Carfilzomib randomised to the two study groups. Of these randomised patients, 99 completed the study (61 men, 38 women): 49 patients were randomised to group N and 50 patients to group C (see Figure Figure11 for trial flow).Figure 1Flow diagram of progress through the phases of this randomised trial for the two groups.The two groups were well matched in terms of age, sex, baseline morbidity, risk factors for Candida infection, and reason for admission to the ICU. The mean age was 56 �� 20 years and the mean Sequential Organ Failure Assessment score was 7 �� 2. The reason for ICU admission was abdominal surgery in 15 patients, neurosurgery in 45 patients, and trauma in 39 patients. The most frequent risk factors for Candida infection were central venous catheters (n = 99), followed by antibiotic therapy (n = 82) and parenteral nutrition (n = 56). The duration of mechanical ventilation as well as the ICU stay were similar between the two groups (Table (Table11).