title: Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  This trial shows that nystatin prophylaxis significantly reduces fungal colonisation in surgical/trauma ICU patients, even if already colonised.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01495039.
authors.affiliation: Anaesthesia and Intensive Care Unit, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, Bari 70124, Italy.
authors.forename: Mariateresa
authors.initials: M
authors.lastname: Giglio
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Caggiano
authors.forename: Lidia
authors.initials: L
authors.lastname: Dalfino
authors.forename: Nicola
authors.initials: N
authors.lastname: Brienza
authors.forename: Ilaria
authors.initials: I
authors.lastname: Alicino
authors.forename: Aurelia
authors.initials: A
authors.lastname: Sgobio
authors.forename: Antonella
authors.initials: A
authors.lastname: Favale
authors.forename: Caterina
authors.initials: C
authors.lastname: Coretti
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Montagna
authors.forename: Francesco
authors.initials: F
authors.lastname: Bruno
authors.forename: Filomena
authors.initials: F
authors.lastname: Puntillo
mesh_terms: D000284:Administration, Oral; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002177:Candidiasis / Q000517:prevention & control*; D016009:Chi-Square Distribution; D003422:Critical Care / Q000379:methods*; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D009761:Nystatin / Q000008:administration & dosage / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D009761:Nystatin