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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00802854
First received: December 3, 2008
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint on Final efficacy. - Clinical response - Mycological response - Overall response (consisting of a combination of both clinical and mycological response). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Endpoint on Safety. - Incidence of adverse event. - Others, abnormal finding from laboratory test (if any). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Unexpected adverse event (especially, occurrence of serious adverse events). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • The circumstantial factor of adverse event appearing under after maintained certain drug. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Factors affecting safety. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Factors affecting efficacy. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]

Enrollment: 244
Study Start Date: March 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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 new medicine on 30 May 2008. As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), safety and effectiveness information of new medication should have been provided certain number of subjects administered in the setting of routine practice during the initial 6 years after the approval (until 29 May 2014). However, all required subject had not enrolled during the original reexamination period (30 May 2008 ~ 29 May 2014). Therefore, according to an order from MFDS in 02 Mar 2015, Eraxis PMS was required to collect rest of all required subjects by 02 September 2016 in prospective and restrospective approach.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

200 subjects will be studied according to the review result by the MFDS for the request for the adjustment of number of subjects.

To achieve the target sample size, the study is being conducted in prospective study design and retrospective study design.

  1. Prospective Study -Subjects will be enrolled by continuous registration method.
  2. Retrospective Study -Physician should enroll patients consecutively who had received at least one dose of Eraxis IV after Eraxis IV approval date (30 May 2008).
Criteria
  1. 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.

    1.2. 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).
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802854

Locations
Korea, Republic of
Chonbuk National University Hospital
Deokjin-gu, Jeollabuk-do, Korea, Republic of, 561-712
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Dong-A University Medical Center (Dong-A University Hospital)
Busen, Korea, Republic of, 602-715
Keimyung University Dongsan Medical Center (KUDMC)
Daegu, Korea, Republic of, 700-712
Daegu fatima hospital
Daegu, Korea, Republic of, 701-724
Daegu Catholic University Medical Center (DCUMC)
Daegu, Korea, Republic of, 705-718
Ajou University Hospital
Gyeonggi-do, Korea, Republic of, 443-721
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Seoul Medical Center
Seoul, Korea, Republic of, 131-795
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00802854     History of Changes
Other Study ID Numbers: A8851025 
Study First Received: December 3, 2008
Last Updated: July 11, 2016
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Pfizer:
anidulafungin
safety
efficacy

Additional relevant MeSH terms:
Abdominal Abscess
Peritonitis
Candidemia
Candidiasis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Fungemia
Sepsis
Candidiasis, Invasive
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Abscess
Suppuration

ClinicalTrials.gov processed this record on December 07, 2016