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

• ClinicalTrials.gov Identifier: NCT01122368
• Recruitment Status: Completed
• First Posted: May 13, 2010
• Last Update Posted: September 1, 2017
• Sponsor: Astellas Pharma Inc
• Information provided by (Responsible Party): Astellas Pharma Inc

Tracking Information

• First Submitted Date: May 10, 2010
• First Posted Date: May 13, 2010
• Last Update Posted Date: September 1, 2017
• Actual Study Start Date: July 13, 2010
• Actual Primary Completion Date: December 15, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2010)

• The incidence of Invasive Fungal Infection [ Time Frame: During treatment ]
• Time from baseline to the first confirmation of Invasive Fungal Infection [ Time Frame: Baseline to End of Treatment visit ]

Original Primary Outcome Measures (submitted: May 12, 2010)

• The incidence of Invasive Fungal Infection [ Time Frame: During treatment (no timeframe noted) ]
• Time from baseline to the first confirmation of Invasive Fungal Infection [ Time Frame: Baseline to End of Treatment visit ]

Current Secondary Outcome Measures (submitted: May 12, 2010)

• 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) [ Time Frame: At the EOT visit ]
• The emergence or persistence of fungal colonization [ Time Frame: At the EOT visit ]
• The level of organ dysfunction [ Time Frame: At the EOT visit ]
• To assess the requirement for additional abdominal surgery/intervention. [ Time Frame: At the End of Study visit ]
• Organ failure-free days [ Time Frame: From Day 1 until 28 days after end of study drug treatment ]
• Fungal-free survival [ Time Frame: From Day 1 until 28 days after end of study drug treatment ]
• Intensive Care Unit (ICU)-free days [ Time Frame: From Day 1 until 28 days after end of study drug treatment ]
• All-cause mortality [ Time Frame: At the End of Study and Long-Term Follow Up visit ]
• Health-related quality of life [ Time Frame: At the End of Study visit ]
• Assessment of the safety of micafungin when used as a pre-emptive treatment [ Time Frame: At the End of Study visit ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
• Official Title: 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
• 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)

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Mycoses

Intervention

• Drug: micafungin
  IV
  Other Names:

  • FK463
  • mycamine
• Drug: placebo
  IV

Study Arms

• Experimental: 1 Micafungin
  IV
  Intervention: Drug: micafungin
• Placebo Comparator: 2 Placebo
  IV
  Intervention: Drug: placebo

• Publications *: Knitsch W, Vincent JL, Utzolino S, François B, Dinya T, Dimopoulos G, Özgüneş İ, Valía JC, Eggimann P, León C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections. Clin Infect Dis. 2015 Dec 1;61(11):1671-8. doi: 10.1093/cid/civ707. Epub 2015 Aug 13.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2012): 252
• Original Estimated Enrollment (submitted: May 12, 2010): 250
• Actual Study Completion Date: December 15, 2011
• Actual Primary Completion Date: December 15, 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Romania, Spain, Switzerland, Turkey, United Kingdom

Administrative Information

• NCT Number: NCT01122368
• Other Study ID Numbers: 9463-EC-0002; 2008-006409-18 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

• Responsible Party: Astellas Pharma Inc
• Study Sponsor: Astellas Pharma Inc
• Collaborators: Not Provided

Investigators

• Study Chair: Use Central Contact; Astellas Pharma Europe Ltd.

• PRS Account: Astellas Pharma Inc
• Verification Date: August 2017