An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Tracking Information
Start Date ICMJE | August 2009 |
---|---|
Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 9, 2008) | Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy in the modified intent to treat (MITT) group [ Time Frame: At end of intravenous treatment (Day 10 - 42) ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00806351 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 9, 2008) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System |
---|---|
Official Title ICMJE | Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection |
Brief Summary | The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
|
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 45 | ||||
---|---|---|---|---|---|
Estimated Completion Date | October 2012 | ||||
Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 16 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Bulgaria, Canada, France, Italy, Netherlands, Poland, Russian Federation, Slovakia, Switzerland |
Administrative Information
NCT ID ICMJE | NCT00806351 | ||||
---|---|---|---|---|---|
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A8851021 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/