Clinical Trial: Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critica

Brief Summary: Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.

Detailed Summary:
Sponsor: Mycoses Study Group

Current Primary Outcome: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. [ Time Frame: Within 7 days after end of therapy ]

Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.


Original Primary Outcome: The primary endpoint is the incidence of proven and probable invasive candidiasis based on the modified EORTC/MSG criteria which includes serological evidence. [ Time Frame: A recent open label study with fluconazole using criteria similar to this study showed a 10 fold reduction of cases of IC in a medical ICU when compared to the previous year when no prophylaxis was used. ]

Current Secondary Outcome:

  • Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. [ Time Frame: Within 7 days of end of therapy ]
  • All Cause Mortality [ Time Frame: Within 7 days of end of therapy ]
  • Initiation of Other Antifungals [ Time Frame: Within 7 days after end of therapy ]
  • Time to Development of Proven or Probable Invasive Candidiasis [ Time Frame: Within 7 days after end of therapy ]
  • Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. [ Time Frame: Within 7 days after end of therapy ]
  • Time to Beta Glucan Negativity in Pre-emptive Phase. [ Time Frame: Within 14 days after end of therapy ]
  • Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase. [ Time Frame: Within 14 days after end of therapy ]
  • Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available. [ Time Frame: Hospital discharge ]
  • Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event [ Time Frame: Up to 14 days after end of therapy ]
  • Subjects With 1 or More Serious Drug-related Adverse Event(s) [ Time Frame: Up to 14 days after end of therapy ]


Original Secondary Outcome: verify a prediction rule for IC; evaluate caspofungin prophylaxis for IC; evaluate prophylaxis & pre-emptive therapy on mortality; evaluate prophylaxis and pre-emptive therapy-hospital metrics. [ Time Frame: The secondary analysis will also examine differences in time to event. ]

Information By: Mycoses Study Group

Dates:
Date Received: August 21, 2007
Date Started: August 2007
Date Completion:
Last Updated: April 8, 2011
Last Verified: April 2011