Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Policlinico Hospital

Status and phase: Completed; Phase 4

Conditions: Candida Infection; Fungal Prophylaxis; Surgery; Critical Illness

Treatments: Drug: Nystatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01495039

Nista 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups, including a placebo group

Nystatin

Active Comparator group

Description:

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)

Treatment:

Drug: Nystatin

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Nystatin