Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fungal Prophylaxis, Candida Infection, Critical Illness, Surgery

Intervention / Treatment
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* Drug: Nystatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nystatin<br>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<br>* Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)<br>* Other names: Mycostatin;|
| Placebo Comparator: Control<br>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<br>* Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)<br>* Other names: Mycostatin;|

What is the study measuring?
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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 |