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

NCT ID: NCT00802854

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 244 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-02
• Study Completion Date: 2016-05-20

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 compliance with the regulation "Re-examination Guideline of New Drugs".

1. Serious adverse event/adverse drug reaction

2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.

3. Known adverse drug reaction

4. Non-serious adverse drug reaction

5. Other safety and effectiveness information Eraxis was first approved as a new medicine on 30 May 2008. As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug(until 29 May 2014).

However, minimal required number of subjects was not met during the original reexamination period (30 May 2008 ~ 29 May 2014). Therefore, according to an order from MFDS on 02 Mar 2015, Eraxis PMS was requested to collect the rest of required subjects by 02 September 2016 in prospective and retrospective approach.

Conditions

Candidemia; Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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)

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Chonbuk National University Hospital

Deokjin-gu, Jeollabuk-do, South Korea

Dong-A University Hospital

Busan, , South Korea

Dong-A University Medical Center (Dong-A University Hospital)

Busen, , South Korea

Keimyung University Dongsan Medical Center (KUDMC)

Daegu, , South Korea

Daegu fatima hospital

Daegu, , South Korea

Daegu Catholic University Medical Center (DCUMC)

Daegu, , South Korea

Ajou University Hospital

Gyeonggi-do, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Seoul Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851025&StudyName=Post%20Marketing%20Surveillance%20Study%20To%20Observe%20Safety%20And%20Efficacy%20Of%20Eraxis%AE%20IV

To obtain contact information for a study center near you, click here.

Other Identifiers

A8851025

Identifier Type: -

Identifier Source: org_study_id