A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

Study Overview
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Brief Summary
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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
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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)

Official Title
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An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

Conditions
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Mycoses

Intervention / Treatment
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* Drug: micafungin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Micafungin<br>IV | Drug: micafungin<br>* IV<br>* Other names: mycamine;|
| Placebo Comparator: 2 Placebo<br>IV | Drug: placebo<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Fungal-free survival |  | From Day 1 until 28 days after end of study drug treatment | 
| 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 | 
| Assessment of the safety of micafungin when used as a pre-emptive treatment |  | At the End of Study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mycoses, Micafungin, intra-abdominal surgery, invasive fungal infection, intra-abdominal infection