Skip to main content
OpenTrials
Completed

NCT Number: NCT01122368

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innsbruck, Austria

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin

Drug

IV

Other names: FK463, mycamine

Placebo

Drug

IV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: INTENSE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2010
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.