Fungal Prophylaxis, Candida Infection, Critical Illness, Surgery
Conditions
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.
Interventions
DRUGNystatin
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
Sponsors
Policlinico Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed