Clinical Trials Logo
  1. Home
  2. Candidiasis
  3. NCT00056368
  4. Details
NCT00056368 Clinical Trial

The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis

Candidiasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00056368
Other study ID # VER002-9
Secondary ID A8851002
Status Completed
Phase Phase 3
First received March 11, 2003
Last updated October 17, 2008
Start date March 2003
Est. completion date October 2004

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anidulafungin

• Fluconazole

Locations
Country Name City State
United States Versicor, Inc. King of Prussia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Terminated NCT01982071 - A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia Phase 4
Completed NCT02391532 - Effect of Probiotic Bacteria on Oral Candida in Frail Elderly N/A
Completed NCT01447407 - Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine Phase 1
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00105144 - Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Phase 3
Completed NCT00163111 - A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood. Phase 3
Completed NCT00138502 - Funguria in Hospitalized Patients
Not yet recruiting NCT04502277 - Bioavailability of Flucanazole Early Phase 1
Completed NCT03203551 - Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous. N/A
Completed NCT05044156 - Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Completed NCT01322698 - Staging Candidiasis in ICU Patients N/A
Terminated NCT01092832 - A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients Phase 3
Terminated NCT00095316 - Caspofungin Study for Fungal Infections in Adults in Critical Care Settings Phase 3
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT02641717 - Validity of Patient-Collected Wet Mounts N/A
Recruiting NCT01253954 - A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China N/A
Completed NCT00797420 - Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers Phase 1
Completed NCT00734539 - Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight Phase 3
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
Completed NCT02666716 - Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients