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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122368
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE May 13, 2010
Last Update Posted Date September 1, 2017
Actual Study Start Date  ICMJE July 13, 2010
Actual Primary Completion Date December 15, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mycoses
Intervention  ICMJE
  • Drug: micafungin
    IV
    Other Names:
    • FK463
    • mycamine
  • Drug: placebo
    IV
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2012)
252
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2010)
250
Actual Study Completion Date  ICMJE December 15, 2011
Actual Primary Completion Date December 15, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Romania,   Spain,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122368
Other Study ID Numbers  ICMJE 9463-EC-0002
2008-006409-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
PRS Account Astellas Pharma Inc
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP