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Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

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ClinicalTrials.gov Identifier: NCT01495039
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Filomena Puntillo, Policlinico Hospital

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.


Condition or disease Intervention/treatment Phase
Fungal Prophylaxis Candida Infection Critical Illness Surgery Drug: Nystatin Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds
Drug Information available for: Nystatin

Arm Intervention/treatment
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

Placebo Comparator: 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.
Drug: Nystatin
Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
Other Name: Mycostatin




Primary Outcome Measures :
  1. course of the colonization index over time. [ Time Frame: 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 Outcome Measures :
  1. The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

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