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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mycoses Drug: micafungin Drug: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 13, 2010
Actual Primary Completion Date : December 15, 2011
Actual Study Completion Date : December 15, 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Micafungin
IV
 Drug: micafungin
IV
Other Names:
  • FK463
  • mycamine
Placebo Comparator: 2 Placebo
IV
 Drug: placebo
IV


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of Invasive Fungal Infection [ Time Frame: During treatment ]
  2. Time from baseline to the first confirmation of Invasive Fungal Infection [ Time Frame: Baseline to End of Treatment visit ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122368


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01122368    
Other Study ID Numbers: 9463-EC-0002
2008-006409-18 ( EudraCT Number )
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (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.
Keywords provided by Astellas Pharma Inc:
mycoses
Micafungin
intra-abdominal surgery
invasive fungal infection
intra-abdominal infection
Additional relevant MeSH terms:
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Mycoses
Candidiasis
Candidiasis, Invasive
Invasive Fungal Infections
 Micafungin
Antifungal Agents
Anti-Infective Agents