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
This study has been terminated.
(The study was prematurely terminated on May 18, 2012 due to slow enrollment. The study was not terminate due to any safety issues or concerns.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00806351
First received: November 26, 2008
Last updated: November 20, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fungemia Neutropenia Candidiasis |
Drug: Active Anidulafungin Drug: Active Caspofungin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Global Response at End of Intravenous Treatment (EOIVT) [ Time Frame: Day 10 up to Day 42 ] [ Designated as safety issue: No ]Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms [s/s] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up [f/u] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to [≥3] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species [sp]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Secondary Outcome Measures:
- Global Response at End of Treatment (EOT) [ Time Frame: Day 14 up to Day 56 ] [ Designated as safety issue: No ]Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
- Global Response at 2-Week Follow-Up Visit [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
- Global Response at 6-Week Follow-Up Visit [ Time Frame: 6 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
- Response Based on Clinical Cure and Microbiological Success at EOIVT [ Time Frame: Day 10 up to Day 42 ] [ Designated as safety issue: No ]Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).
- Response Based on Clinical Cure and Microbiological Success at EOT [ Time Frame: Day 14 up to Day 56 ] [ Designated as safety issue: No ]Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).
- Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).
- Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit [ Time Frame: 6 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).
- Clinical Response at Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.
- Number of Participants With Recurrence [ Time Frame: 2 and 6 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.
- Number of Participants With New Infections [ Time Frame: 2 and 6 weeks post treatment ] [ Designated as safety issue: No ]Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.
- Time to First Negative Blood Culture for Candida Species [ Time Frame: Baseline up to Day 56 ] [ Designated as safety issue: No ]A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.
- Time to Death [ Time Frame: Day 1 up to Day 98 ] [ Designated as safety issue: Yes ]Time to death defined as: date of death minus first treatment date plus 1.
- All-Cause Mortality [ Time Frame: Baseline up to 6 weeks post treatment ] [ Designated as safety issue: Yes ]All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up
| Enrollment: | 21 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Anidulafungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
|
Drug: Active Anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
|
|
Experimental: Caspofungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
|
Drug: Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Dysfunctional immune system (reduced neutrophils).
- Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
- Male of female ≥16 years of age.
- Expected hospitalization for at least ten (10) days.
Exclusion Criteria:
- Pregnancy or breast feeding or planning to become pregnant during the study.
- Recent treatment with one of the study drugs over the last 30 days.
- Allergy to either study drug or to this class of drugs.
- Significant liver dysfunction.
- Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806351
Locations
| Bosnia and Herzegovina | |
| Pfizer Investigational Site | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| France | |
| Pfizer Investigational Site | |
| GRENOBLE Cedex 09, France, 38043 | |
| Pfizer Investigational Site | |
| Strasbourg Cedex, France, 67098 | |
| Italy | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00133 | |
| Poland | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-952 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 02-776 | |
| Pfizer Investigational Site | |
| Wroclaw, Poland, 50-367 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115478 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 04190 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00806351 History of Changes |
| Other Study ID Numbers: | A8851021 |
| Study First Received: | November 26, 2008 |
| Results First Received: | November 20, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia |
Additional relevant MeSH terms:
|
Candidiasis Mycoses Neutropenia Fungemia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Sepsis Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Anidulafungin Echinocandins Caspofungin Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013