Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients

Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate.

Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9…). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Surgery; Fungal Prophylaxis; Candida Infection
• Intervention / Treatment: Drug: Nystatin

Detailed Description

Multiple-site testing for fungi included: tracheal secretions, pharingael swab, stomach contents, rectal swab, groin skin fold swab, urine, and blood. These tests will be performed in each patient at ICU admission (T0) and subsequently every 3 days throughout the ICU stay (T3, T6, T9…), as routine in our ICU.The specimens were placed in a dry medium and taken to the Mycology Laboratory. Group assignment was not indicated on specimens, the mycologists were therefore blinded to treatment allocation.

Each specimen was directly microscopically examined and cultured on Sabouraud media.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70100
    • Intensive care Unit, Policlinico Hospital Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

Exclusion Criteria:

• pregnancy,
• proven Candida infection,
• prophylactic or curative antifungal treatment within the last 2 months,
• contraindication to oral drug administration,
• known allergy to nystatin or its derivatives, and prior inclusion in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nystatin; surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.Patients were allocated to receive systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)	Drug: Nystatin; Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube); Other Names: Mycostatin
Placebo Comparator: Control; surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.	Drug: Nystatin; Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube); Other Names: Mycostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
course of the colonization index over time.	Fungal colonization will be defined as either the presence of the same yeast on one or more of the six distinct body sites tested (blood sample excepted), or on two consecutive specimens from the same body site. Candida Colonisation index (C.I.)was defined as the ratio of the number of distinct body sites colonised with genotypically identical strains of Candida spp (blood excepted) over the total number of sites tested.	AT 15 day from ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay	Fungal infection will be defined as either the presence of a candidemia or the identification of Candida spp. in a normally sterile body site associated with a severe sepsis with negative tests for bacteria or other causes.	At 15 day from ICU admission

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Study Director: Francesco Bruno, Professor, University of Bari, Italy; Principal Investigator: Filomena Puntillo, Professor, University of Bari, Italy

Publications and helpful links

General Publications

• Giglio M, Caggiano G, Dalfino L, Brienza N, Alicino I, Sgobio A, Favale A, Coretti C, Montagna MT, Bruno F, Puntillo F. Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial. Crit Care. 2012 Dec 12;16(2):R57. doi: 10.1186/cc11300.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Critical Illness; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Bacterial Agents; Membrane Transport Modulators; Antifungal Agents; Ionophores; Nystatin
• Other Study ID Numbers: Nista 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No