INTENSE

• Research type

  Research Study

• Full title

  An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Cadidiasis versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-Blind Study

• IRAS ID

  45152

• Contact name

  M C Bellamy

• Sponsor organisation

  Astellas Pharma Ltd.

• Eudract number

  2008-006409-18

• ISRCTN Number

  N/A

• Research summary

  Over the last 20 years, Candida infections (a type of fungal infection) have emerged as a major cause of morbidity and mortality in hospitalized patients. Candida species are currently the 4th most common cause of bloodstream infections in U.S. hospitals where the incidence of fungal bloodstream infections increased more than 3-fold between 1979 and 2000.Fungal infections have now been recognized as a frequent complication in critically ill patients. Estimations show that invasive candidiasis (IC; a fungal infection in the bloodstream) affects around 2% of the general intensive care unit (ICU) patient population. Despite introduction of new antifungal drugs and advances in the supportive management of critically ill patients, candida infections remain associated with crude and attributable mortality of 40 to 60% and 30 to 40%, respectively. Patients undergoing surgery (especially gastrointestinal) are considered to be at particularly high risk of developing IC due to their underlying severity of illness, impaired integrity of gastrointestinal lining and frequency of treatment with broad-spectrum antibiotics and parenteral nutrition.It has been demonstrated that early introduction of antifungal therapy is essential for the control of infection and favorable clinical outcomes. Observational studies have shown that delayed introduction of antifungal treatment of Candidemia is associated with worse outcomes: when antifungal therapy was initiated within 24 hours of drawing the first positive blood culture, the mortality was 15 to 19%, compared with 33% where initiated after 24 hours.In this study, patients with an intra-abdominal infection requiring surgery and ICU stay will be randomised to receive either micafungin or placebo as a pre-emptive treatment for invasive fungal infection. An independent data-review board will make a blinded assessment of the incidence of and time to confirmed invasive fungal infection in both study arms.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/21

• Date of REC Opinion

  5 Aug 2010

• REC opinion

  Further Information Favourable Opinion