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

Mycoses Clinical Trial

— INTENSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122368
• Other study ID #: 9463-EC-0002
• Secondary ID: 2008-006409-18
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2010
• Last updated: August 31, 2017
• Start date: July 13, 2010
• Est. completion date: December 15, 2011

Study information

• Verified date: August 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 15, 2011
• Est. primary completion date: December 15, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Mycoses

Intervention

Drug:
• micafungin
IV
• placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Romania,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Invasive Fungal Infection		During treatment
Primary	Time from baseline to the first confirmation of Invasive Fungal Infection		Baseline to End of Treatment visit
Secondary	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)		At the EOT visit
Secondary	The emergence or persistence of fungal colonization		At the EOT visit
Secondary	The level of organ dysfunction		At the EOT visit
Secondary	To assess the requirement for additional abdominal surgery/intervention.		At the End of Study visit
Secondary	Organ failure-free days		From Day 1 until 28 days after end of study drug treatment
Secondary	Fungal-free survival		From Day 1 until 28 days after end of study drug treatment
Secondary	Intensive Care Unit (ICU)-free days		From Day 1 until 28 days after end of study drug treatment
Secondary	All-cause mortality		At the End of Study and Long-Term Follow Up visit
Secondary	Health-related quality of life		At the End of Study visit
Secondary	Assessment of the safety of micafungin when used as a pre-emptive treatment		At the End of Study visit

External Links

•   Link to results on the Astellas Clinical Study Results website.