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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nystatin | Active Comparator | 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) |
|
| Control | Placebo Comparator | surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nystatin | Drug | Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Bruno, Professor | University of Bari | Study Director |
| Filomena Puntillo, Professor | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care Unit, Policlinico Hospital Bari | Bari | Italy | 70100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22490643 | Derived | Giglio M, Caggiano G, Dalfino L, Brienza N, Alicino I, Sgobio A, Favale A, Coretti C, Montagna MT, Bruno F, Puntillo F. Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial. Crit Care. 2012 Dec 12;16(2):R57. doi: 10.1186/cc11300. |
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| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D009761 | Nystatin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |