Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
NCT00802854
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | ||||
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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".
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.
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Condition |
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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 | 244 | |||
Original Estimated Enrollment | 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 |
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.
Subjects presenting with any of the following will not be included in the study:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | October 2018 |