Clinical trial NCT00802854: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Keywords: anidulafungin
safety
efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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).

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Duration of Adverse Events (AEs)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Adverse Events (AEs) by Severity
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Outcome in Response to Adverse Events (AEs)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Clinical Response (CR)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Mycological Response (MR)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
measure: Number of Participants With Overall Response (OR)
timeFrame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Secondary outcomes:
Other outcomes:
Locations:
city: Deokjin-gu
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busen
country: Korea, Republic of
facility: Dong-A University Medical Center (Dong-A University Hospital)
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center (KUDMC)
city: Daegu
country: Korea, Republic of
facility: Daegu fatima hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center (DCUMC)
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: