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

Last updated on December 5, 2018

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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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample

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).
  • Candidemia
  • Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
May 2016
May 2016   (Final data collection date for primary outcome measure)
  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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00802854
A8851025
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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