Mycoses
Conditions
Keywords
mycoses, Micafungin, intra-abdominal surgery, invasive fungal infection, intra-abdominal infection
Brief summary
Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.
Detailed description
Subjects will be assessed at the following visits: * Baseline (after surgery, prior to randomization) * End of Treatment (EOT) visit (EOT is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death) * End of Study visit (28 days after the EOT visit) * Long-term Follow up visit (90 days after the EOT visit)
Interventions
DRUGmicafungin
IV
DRUGplacebo
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intra-abdominal infection requiring surgery and Intensive Care Unit stay * If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours * If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours * 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
Exclusion criteria
* Acute pancreatitis * Neutropenia (ANC \<1,000/mm3) at the time of randomization * Infected intra-peritoneal dialysis * Patients undergoing solid organ transplantation * Documented invasive candidiasis at the time of randomization * Expected survival \< 48 hours * Any systemically active anti-fungal within 14 days prior to administration of the study drug * Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients * Currently receiving and/or has taken an investigational drug within 28 days prior to randomization * Pregnant woman or breast-feeding mother * 'Do Not Resuscitate' order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Invasive Fungal Infection | During treatment |
| Time from baseline to the first confirmation of Invasive Fungal Infection | Baseline to End of Treatment visit |
Secondary
| Measure | Time frame |
|---|---|
| The emergence or persistence of fungal colonization | At the EOT visit |
| The level of organ dysfunction | At the EOT visit |
| To assess the requirement for additional abdominal surgery/intervention. | At the End of Study visit |
| Organ failure-free days | From Day 1 until 28 days after end of study drug treatment |
| Assessment of the safety of micafungin when used as a pre-emptive treatment | At the End of Study visit |
| Intensive Care Unit (ICU)-free days | From Day 1 until 28 days after end of study drug treatment |
| All-cause mortality | At the End of Study and Long-Term Follow Up visit |
| Health-related quality of life | At the End of Study visit |
| Fungal-free survival | From Day 1 until 28 days after end of study drug treatment |
| The incidence during the treatment period and the time to confirmation of the composite endpoint (defined as confirmation of Invasive Fungal Infection and/or administration of alternative anti-fungal therapy) | At the EOT visit |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Romania, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed