The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
NCT00041704
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- Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)
- Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast
- Pregnant female
- Hypersensitivity to anidulafungin or echinocandin therapy
- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
- Abnormal blood chemistries: Bilirubin >2 times the upper limit of normal; AST
(aspartate aminotransferase) or ALT (alanine aminotransferase) > 4 times the upper
limit of normal
- Less than four weeks since prior participation in an investigational drug or device
study with the exception of antiretroviral agents or licensed agents
- Patients taking other systemic antifungal therapies while on this study
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC) | ||
| Official Title ICMJE | A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis. | ||
| Brief Summary | Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Candidiasis | ||
| Intervention ICMJE | Drug: Anidulafungin, VER002 | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 19 | ||
| Original Enrollment ICMJE | 20 | ||
| Actual Study Completion Date ICMJE | August 2004 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | 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 | NCT00041704 | ||
| Other Study ID Numbers ICMJE | VER002-11 A8851004 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | 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 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||