Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Phase 4

Completed

• Conditions: Critical Illness; Fungal Prophylaxis; Candida Infection; Surgery
• Interventions: Drug: Nystatin

• Registration Number: NCT01495039
• Lead Sponsor: Policlinico Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2008-11
• Primary Completion: 2009-08
• Study Completion: 2010-02
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-19
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nystatin	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)
Control	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.

Primary Outcome Measures

Name	Time	Method
course of the colonization index over time.	AT 15 day from ICU admission	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.

Secondary Outcome Measures

Name	Time	Method
The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay	At 15 day from ICU admission	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.

Trial Locations

Locations (1)

Intensive care Unit, Policlinico Hospital Bari; 🇮🇹 Bari, Italy