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.

Study Overview

• Status: Completed
• Conditions: Candidemia; Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)

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
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-715
    • Dong-A University Hospital
  • Busen, Korea, Republic of, 602-715
    • Dong-A University Medical Center (Dong-A University Hospital)
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center (KUDMC)
  • Daegu, Korea, Republic of, 701-724
    • Daegu fatima hospital
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center (DCUMC)
  • Gyeonggi-do, Korea, Republic of, 443-721
    • Ajou University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 131-795
    • Seoul Medical Center
  • Jeollabuk-do
    • Deokjin-gu, Jeollabuk-do, Korea, Republic of, 561-712
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Duration of Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Adverse Events (AEs) by Severity	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Outcome in Response to Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved).	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)	AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)*100.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Laboratory Abnormalities	Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Clinical Response (CR)	CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Mycological Response (MR)	In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Number of Participants With Overall Response (OR)	OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection.	From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2012
• Primary Completion (Actual): May 20, 2016
• Study Completion (Actual): May 20, 2016

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: safety; efficacy; anidulafungin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Peritoneal Diseases; Bacterial Infections and Mycoses; Sepsis; Mycoses; Invasive Fungal Infections; Fungemia; Suppuration; Intraabdominal Infections; Abscess; Candidiasis, Invasive; Candidiasis; Candidemia; Peritonitis; Abdominal Abscess
• Other Study ID Numbers: A8851025