critically ill patients
Conditions
Interventions
Trade Name: MYCOSTATIN*OS SOSP FL 100ML
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Nystatin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentr
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed