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Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Filomena Puntillo, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01495039
First received: December 12, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Fungal Prophylaxis
Candida Infection
Critical Illness
Surgery
Drug: Nystatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients

Resource links provided by NLM:


Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • course of the colonization index over time. [ Time Frame: AT 15 day from ICU admission ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 15 day from ICU admission ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nystatin
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
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
Other Name: Mycostatin
No Intervention: Control
Surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h that received no nystatin prophylaxis
Drug: Nystatin
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
Other Name: Mycostatin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495039

Locations
Italy
Intensive care Unit, Policlinico Hospital Bari
Bari, Italy, 70100
Sponsors and Collaborators
Policlinico Hospital
Investigators
Study Director: Francesco Bruno, Professor University of Bari, Italy
Principal Investigator: Filomena Puntillo, Professor University of Bari, Italy
  More Information

No publications provided by Policlinico Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filomena Puntillo, Professor, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01495039     History of Changes
Other Study ID Numbers: Nista 1
Study First Received: December 12, 2011
Last Updated: December 16, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Candidiasis
Critical Illness
Disease Attributes
Mycoses
Pathologic Processes
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014