The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00056368
First received: March 11, 2003
Last updated: October 17, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidiasis |
Drug: Anidulafungin Drug: Fluconazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
| Enrollment: | 256 |
| Study Start Date: | March 2003 |
| Study Completion Date: | October 2004 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Diagnosis of candidemia and/or other forms of invasive candidiasis.
- Should not have received greater than 48 hours of systemic antifungal therapy.
- Life expectancy should be greater than 72 hours.
- Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment
Contacts and Locations More Information
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00056368 History of Changes |
| Other Study ID Numbers: | VER002-9, A8851002 |
| Study First Received: | March 11, 2003 |
| Last Updated: | October 17, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Candida blood stream infections Candida infections Candidemia Invasive Candidiasis |
Additional relevant MeSH terms:
|
Candidiasis Candidemia Candidiasis, Invasive Mycoses Fungemia Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Fluconazole Anidulafungin Echinocandins Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013