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

Astellas

Status and phase

Completed

Phase 2

Conditions

Mycoses

Treatments

Drug: micafungin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01122368

9463-EC-0002

2008-006409-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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)

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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