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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

Last updated on March 14, 2019

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Study Location
Chonbuk National University Hospital
Deokjin-gu, Jeollabuk-do, 561-712 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidemia, Peritonitis) Other Forms of Candida Infections(Intra-abdominal Abscess
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects must meet all of the following inclusion criteria to be eligible for
enrollment into the study:

- Use in the treatment of invasive candidiasis in adult patients

- Evidence of a personally signed and dated data privacy statement indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects presenting with any of the following will not be included in the study:

- Subjects to whom Eraxis IV is prescribed for other diseases than invasive
candidiasis in adult patients.

- Subjects less than 18 ages should be excluded in this study since safety and
effectiveness in pediatric patients have not been established yet.

- Hypersensitivity to the active substance, or to any of the excipients.

- Hypersensitivity to other medicinal products of the echinocandin class (e.g.
caspofungin).

2. Retrospective Study Population 2.1. Inclusion Criteria

Subjects must meet one of the following inclusion criteria to be eligible for enrollment
into the study:

Since all subjects enrolled should meet the usual prescribing criteria as per the local
product document of Eraxis IV at the time of starting Eraxis IV administration, the
inclusion criteria is divided as followings on the basis of 10 Mar 2015 when the approved
indication was updated.

- In case where the starting date of Eraxis IV administration is prior to 10 Mar 2015 -
Use in the treatment of the following fungal infections: candidemia and other forms of
Candida infections (intra-abdominal abscess, and peritonitis)

- In case where the starting date of Eraxis IV administration is 10 Mar 2015 or after -
Use in the treatment of invasive candidiasis in adult patients 2.2. Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

- Subjects to whom Eraxis IV was prescribed for other diseases than candidemia and other
forms of Candida infections (intra-abdominal abscess, and peritonitis) (in case where
the starting date of Eraxis IV administration is prior to 10 Mar 2015) or invasive
candidiasis in adult patients (in case where the starting date of Eraxis IV
administration is 10 Mar 2015 or after).

- Subjects less than 18 ages should be excluded in this study since safety and
effectiveness in pediatric patients have not been established yet.

- Hypersensitivity to the active substance, or to any of the excipients.

- Hypersensitivity to other medicinal products of the echinocandin class (e.g.
caspofungin).

- Subjects enrolled in the prospective phase study.

NCT00802854
Pfizer
Completed
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

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