Invasive Candidiasis MedDRA version: 12.1 Level: LLT Classification code 10007152 Term: Candidiasis MedDRA version: 12.1 Level: LLT Classification code 10007162 Term: Candidiasis of the intestine
Conditions
Interventions
Trade Name: Mycamine
Product Name: Micafungin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: MICAFUNGIN
CAS Number: 235114-32-6
Current Sponsor code: FK463
Concentration un
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.= 18 years of age. 2.Intra-abdominal infection requiring surgery and ICU stay. 3.If CAI, duration of ICU stay of = 72 hrs (but not more than 120 hours), counted from the end of surgery, and a further expected duration of ICU stay of = 48 hours or more. 4.If NAI, duration of ICU stay of = 48 hrs, counted from the end of surgery, and a further expected duration of ICU stay of = 48 hours or more. 5.Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study. contraceptives, some IUDs, sexual abstinence or vasectomised partner. 6.The subject has been fully informed and has given written informed consent to participate in the study. 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: 1. Acute pancreatitis. 2. Neutropenia (ANC < 1,000/mm3) at the time of randomization. 3. Infected intra-peritoneal dialysis. 4. Patients undergoing solid organ transplantation. 5. Documented invasive candidiasis at the time of randomization. 6. Expected survival < 48 hours. 7. Any systemically active anti-fungal administered within 14 days prior to administration of the study drug. 8. Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients. 9. Currently receiving and/or has taken an investigational drug within 28 days prior to randomization.. 10. Pregnant woman or breast-feeding mother. 11. ‘Do Not Resuscitate’ order. 12. The subject, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol. 13. The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, in the opinion of the Investigator, contraindicates their participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess the incidence of invasive candidiasis at EOT assess the time to invasive candidiasis at EOT;Secondary Objective: To assess the incidence and time to confirmation of the composite endpoint at EOT visit (defined as IFI and/or administration of alternative anti-fungal therapy). To assess the emergence or persistence of fungal colonization at EOT. To assess the level of organ dysfunction: Change in sequential organ failure assessment (SOFA) score over time, Need for re-intubation, Need for renal support, Need for vasopressor support, To assess the requirement for additional abdominal surgery/intervention. To investigate: All-cause mortality at 28 days and 90 days after end of study drug treatment; Organ failure-free days from Day 1 until 28 days after end of study drug treatment; Fungal-free survival up to 28 days after end of study drug treatment; ICU-free days from Day 1 until 28 days after end of study drug treatment To assess resource use and health-related quality of life at the End of Study (EOS) visit. To assess the safety of micafungin when used as pre-emptive treatment.;Primary end point(s): Incidence of invasive fungal infection Time to invasive fungal infection | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed