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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00806351
Other study ID # A8851021
Secondary ID
Status Terminated
Phase Phase 3
First received November 26, 2008
Last updated November 20, 2012
Start date August 2009
Est. completion date October 2011

Study information

Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Active Anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin

Locations

Country Name City State
Bosnia and Herzegovina Pfizer Investigational Site Sarajevo
France Pfizer Investigational Site GRENOBLE Cedex 09
France Pfizer Investigational Site Strasbourg Cedex
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Roma
Poland Pfizer Investigational Site Gdansk
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wroclaw
Russian Federation Pfizer Investigational Site Moscow
Slovakia Pfizer Investigational Site Kosice

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Bosnia and Herzegovina,  France,  Italy,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global Response at End of Intravenous Treatment (EOIVT) 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). Day 10 up to Day 42
Secondary Global Response at End of Treatment (EOT) 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). Day 14 up to Day 56
Secondary Global Response at 2-Week Follow-Up Visit 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). 2 weeks post treatment
Secondary Global Response at 6-Week Follow-Up Visit 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). 6 weeks post treatment
Secondary Response Based on Clinical Cure and Microbiological Success at EOIVT 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]). Day 10 up to Day 42
Secondary Response Based on Clinical Cure and Microbiological Success at EOT 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]). Day 14 up to Day 56
Secondary Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit 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]). 2 weeks post treatment
Secondary Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit 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]). 6 weeks post treatment
Secondary Clinical Response at Day 10 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. Day 10
Secondary Number of Participants With Recurrence 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. 2 and 6 weeks post treatment
Secondary Number of Participants With New Infections 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. 2 and 6 weeks post treatment
Secondary Time to First Negative Blood Culture for Candida Species 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. Baseline up to Day 56
Secondary Time to Death Time to death defined as: date of death minus first treatment date plus 1. Day 1 up to Day 98
Secondary All-Cause Mortality 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 Baseline up to 6 weeks post treatment
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