NCT00056368CompletedPhase 3
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 256
- Locations
- 1
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17NeutropeniaNCT00056381Pfizer25
Completed
Phase 3
Anidulafungin Versus Fluconazole in the Treatment of CandidemiaCandidaCandidiasisNCT00058682National Cancer Institute (NCI)248
Completed
Phase 2
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.CandidiasisNCT00037219Pfizer120
Completed
Phase 2
The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)CandidiasisNCT00041704Pfizer19
Not yet recruiting
Not Applicable
Study of skin features, laboratory features and response to treatment to antifungal drugs in patients with superficial fungal infections.CTRI/2018/04/013045MAHARAJAHS INSTITUTE OF MEDICAL SCIENCES