Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495039
• Other study ID #: Nista 1
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2011
• Last updated: April 3, 2017
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2017
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candida Infection
• Candidiasis
• Critical Illness
• Fungal Prophylaxis
• Surgery

Intervention

Drug:
• Nystatin
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)

Locations

Country	Name	City	State
Italy	Intensive care Unit, Policlinico Hospital Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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