Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
Primary Purpose
Fungal Prophylaxis, Candida Infection, Critical Illness
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Nystatin
Sponsored by
About this trial
This is an interventional prevention trial for Fungal Prophylaxis
Eligibility Criteria
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
Sites / Locations
- Intensive care Unit, Policlinico Hospital Bari
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nystatin
Control
Arm 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)
surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01495039
Brief Title
Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
Official Title
The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Prophylaxis, Candida Infection, Critical Illness, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nystatin
Arm Type
Active Comparator
Arm 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)
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nystatin
Other Intervention Name(s)
Mycostatin
Intervention Description
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
Primary Outcome Measure Information:
Title
course of the colonization index over time.
Description
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.
Time Frame
AT 15 day from ICU admission
Secondary Outcome Measure Information:
Title
The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay
Description
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.
Time Frame
At 15 day from ICU admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Bruno, Professor
Organizational Affiliation
University of Bari, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Filomena Puntillo, Professor
Organizational Affiliation
University of Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive care Unit, Policlinico Hospital Bari
City
Bari
ZIP/Postal Code
70100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22490643
Citation
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.
Results Reference
derived
Learn more about this trial
Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
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