NCT01495039

Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Policlinico Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fungal Prophylaxis
• Candida Infection
• Critical Illness
• Surgery

Interventions

Type	Name	Description
DRUG	Nystatin	Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-08-01
• Completion: 2010-02-01
• First posted: 2011-12-19
• Last updated: 2017-04-05

Locations

1 site across 1 country: Italy