Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial

Abstract

Introduction: Candida prophylaxis in ICU is still a matter of debate. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonisation and infection.

Methods: We performed a randomised trial studying a single drug (nystatin) versus control in surgical/trauma ICU patients. Multiple-site testing for fungi was performed in each patient on ICU admission (T0) and subsequently every 3 days (T3, T6, T9, and so forth). The primary evaluation criterion was the time course of the corrected colonisation index.

Results: Ninety-nine patients were enrolled. At admission, 69 patients exhibited Candida colonisation: the most frequently colonised body sites were the stomach and the pharynx. The most frequent isolated species was Candida albicans. The corrected colonisation index was similar in the two groups at T0 (P = 0.36), while a significant statistical difference was observed between the treatment and control groups at T6 (median 0.14 and 0.33, respectively; P = 0.0016), at T9 (median 0.00 and 0.28, respectively; P = 0.0001), at T12 (median 0.00 and 0.41, respectively; P = 0.0008), and at T15 (median 0.00 and 0.42, respectively; P < 0.0003). The same results were obtained in the subgroup of patients already colonised at ICU admission.

Conclusion: This trial shows that nystatin prophylaxis significantly reduces fungal colonisation in surgical/trauma ICU patients, even if already colonised.

Trial registration: ClinicalTrials.gov: NCT01495039.

Figure 1

Flow diagram of progress through the phases of this randomised trial for the two groups.

Figure 2

Course of the corrected colonisation index over time. Course of the corrected colonisation index (CCI) over time in the treatment group (white bars) and the control group (black bars). Illustrated are the daily median values (filled circles), and the 25th and 75th percentiles - that is, the interquartile range (borders of the box). Data in parentheses are the number of patients in each of the two study groups over time. *P <0.05.

Figure 3

Colonisation of different body sites. Percentage of patients colonised during the study period in four different body sites: stomach, rectum, trachea, and urine. Black bars, control group; white bars, nystatin group. *P <0.05 between groups at every time (T0, T3, and so forth). Pts, patients.

Figure 4

Corrected colonisation index over time in patients already colonised at admission to the ICU. Course of the corrected colonisation index (CCI) over time in the treatment group (white bars) and the control group (black bars), considering only patients who were already colonised at admission to the ICU. Illustrated are the daily median values (filled circles), and the 25th and 75th percentiles - that is, the interquartile range (borders of the box). Data in parentheses are the number of patients in each of the two study groups over time. *P <0.05.