Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
This study has been completed.
Sponsor:
Policlinico Hospital
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
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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
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 Mycoses Disease Attributes Pathologic Processes Nystatin Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 21, 2013