NCT00802854

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Timeline

• Start date: 2012-03-02
• Primary completion: 2016-05-20
• Completion: 2016-05-20
• First posted: 2008-12-05
• Last updated: 2018-11-21
• Results posted: 2017-11-30

Locations

10 sites across 1 country: South Korea