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

November 15, 2024 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
      • Salzburg, Austria, 5020
      • Wien, Austria, 1030
      • Wien, Austria, 1090
  • Belgium
      • Brussels, Belgium, 1200
      • Brussels, Belgium, 1070
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Liege, Belgium, 4000
  • Denmark
      • Viborg, Denmark, 8800
  • Finland
      • Jyvaskyla, Finland, 40620
      • Kuopio, Finland, 70210
      • Tampere, Finland, 33521
  • France
      • Amiens, France, 84054
      • La Roche sur Yon Cedex 9, France, 85925
      • Limoges, France, 87042
      • Paris, France, 75679
      • Paris Cedex 14, France, 75674
      • Pierre Benite, France, 69495
      • Poitiers, France, 86021
  • Germany
      • Freiburg, Germany, 79106
      • Hannover, Germany, 30625
      • Koln, Germany, 50937
      • Leipzig, Germany, 04103
      • Lubeck, Germany, 23562
  • Greece
      • Athens, Greece, 12461
      • Thessaloniki, Greece, 57010
      • Thessaloniki, Greece, 57001
  • Hungary
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9023
      • Szeged, Hungary, 6720
  • Israel
      • Ramat Gan, Israel, 52621
      • Tel Aviv, Israel, 64239
  • Italy
      • Bologna, Italy, 40138
      • Milano, Italy, 20142
      • Monza, Italy, 20052
      • Pisa, Italy, 56126
      • Roma, Italy, 00161
      • Roma, Italy, 00168
      • Verona, Italy, 37126
  • Romania
      • Bucharest, Romania, 50098
      • Oradea, Romania, 410168
      • Timisoara, Romania, 300748
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28006
      • Madrid, Spain, 28046
      • Valencia, Spain, 46014
      • Valladolid, Spain, 47012
  • Switzerland
      • Lausanne, Switzerland, 1011
  • Turkey
      • Ankara, Turkey, 06100
      • Ege, Turkey, 35100
      • Eskisehir, Turkey, 26480
      • Trabzon, Turkey, 61080
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
      • Leeds, United Kingdom, LS1 3EX
      • Leeds, United Kingdom, LS9 7TF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 Micafungin
IV
Drug: micafungin
IV
Other Names:
  • FK463
  • mycamine
Placebo Comparator: 2 Placebo
IV
Drug: placebo
IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of Invasive Fungal Infection
Time Frame: During treatment
During treatment
Time from baseline to the first confirmation of Invasive Fungal Infection
Time Frame: Baseline to End of Treatment visit
Baseline to End of Treatment visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: At the EOT visit
At the EOT visit
The emergence or persistence of fungal colonization
Time Frame: At the EOT visit
At the EOT visit
The level of organ dysfunction
Time Frame: At the EOT visit
At the EOT visit
To assess the requirement for additional abdominal surgery/intervention.
Time Frame: At the End of Study visit
At the End of Study visit
Organ failure-free days
Time Frame: From Day 1 until 28 days after end of study drug treatment
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
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
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
At the End of Study and Long-Term Follow Up visit
Health-related quality of life
Time Frame: At the End of Study visit
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
At the End of Study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Use Central Contact, Astellas Pharma Europe Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9463-EC-0002
  • 2008-006409-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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