Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Policlinico Hospital
• Treatments: Nystatin

Criteria

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