the role of antifungal prophylaxis with oral nystatin in critically ill patients - ND
- Conditions
- critically ill patients
- Registration Number
- EUCTR2008-005832-34-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
18 years of age and expected to require invasive mechanical ventilation for more than 48 h. Trauma patients, neurosurgical or patients undergone general abdominal surgery will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluation of the efficacy of oral nystatin to prevent candida colonisation and the course of the colonization index over time.;Secondary Objective: evaluation of the efficacy of oral nystatin to prevent candida infection.;Primary end point(s): the development of fungal colonization during ICU stay and the course of the colonization index over time.
- Secondary Outcome Measures
Name Time Method