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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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