Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.
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| Descriptive Information | |||
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| Brief Title ICMJE | The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis | ||
| Official Title ICMJE | A Phase III, Double-Blind, Randomized, Multi-Center, Study of the Safety and Efficacy of Anidulafungin vs. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications. | ||
| Brief Summary | Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body. | ||
| Detailed Description | Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment |
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| Condition ICMJE | Candidiasis | ||
| Intervention ICMJE |
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| Study Arms | Not Provided | ||
| Publications * | Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 256 | ||
| Completion Date | October 2004 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE |
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| Sex/Gender |
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| Ages | 16 Years and older (Child, Adult, Senior) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00056368 | ||
| Other Study ID Numbers ICMJE | VER002-9 A8851002 |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Vicuron Pharmaceuticals | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | October 2008 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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1-800-718-1021
