Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE)
Tracking Information
Start Date ICMJE | July 2008 |
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Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 29, 2008) | The primary efficacy endpoint will be the global treatment response at the End of Treatment. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00689338 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 29, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study |
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Official Title ICMJE | Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations |
Brief Summary | To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | Treatment Group: Experimental Option to treat with oral azole therapy following treatment with anidulafungin Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 286 | ||||
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Estimated Completion Date | May 2010 | ||||
Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
Exclusion Criteria: Patients with poor venous access that would preclude IV drug delivery or multiple blood draws. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00689338 | ||||
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Responsible Party | Clinical Trials Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A8851019 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/