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

Last updated on March 25, 2020

FOR MORE INFORMATION
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.
Show details

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.
Show details

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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Descriptive Information
Brief Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Official Title Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Candidemia
  • Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2016)
244
Original Estimated Enrollment
 (submitted: December 3, 2008)
3000
Actual Study Completion Date May 20, 2016
Actual Primary Completion Date May 20, 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00802854
Other Study ID Numbers A8851025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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