Status:
COMPLETED
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Lead Sponsor:
Pfizer
Conditions:
Candidemia
Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.
Detailed Description
The objective of this study is to determine any problems or questions associated with Eraxis after marketing, with regard to the following clauses under conditions of general clinical practice, in com...
Eligibility Criteria
Inclusion
- Prospective Study Population 1.1. Inclusion Criteria
- 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.
- 2. Exclusion Criteria
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
March 2 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 20 2016
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00802854
Start Date
March 2 2012
End Date
May 20 2016
Last Update
November 21 2018
Active Locations (10)
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1
Chonbuk National University Hospital
Deokjin-gu, Jeollabuk-do, South Korea, 561-712
2
Dong-A University Hospital
Busan, South Korea, 602-715
3
Dong-A University Medical Center (Dong-A University Hospital)
Busen, South Korea, 602-715
4
Keimyung University Dongsan Medical Center (KUDMC)
Daegu, South Korea, 700-712