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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00802854
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 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.


Study Design

Study Type : Observational
Actual Enrollment : 244 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.
Study Start Date : March 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  2. Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  3. Duration of Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  4. Number of Adverse Events (AEs) by Severity [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  5. Number of Participants With Outcome in Response to Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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', 'unknown' or 'no-resolved'.

  6. Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. Relatedness of AE to treatment was assessed by physician as: Certain (had clinically reasonable reaction on cessation of the treatment); Probable/likely (followed a reasonable time sequence from administration of treatment which was not explained by other drugs, chemical substance or accompanying diseases); Possible (followed a reasonable time sequence from administration of treatment); Unlikely (not likely to have a reasonable causal relationship with treatment, seems temporary); Conditional/unclassified (needed more data to make an appropriate assessment or its additional data were being reviewed); Unaccessible/unclassifiable (lack of sufficient information hampered accurate causality assessment).

  7. Number of Participants With Laboratory Abnormalities [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  8. Number of Participants With Clinical Response (CR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  9. Number of Participants With Mycological Response (MR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.

  10. Number of Participants With Overall Response (OR) [ Time Frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802854


Locations
Korea, Republic of
Chonbuk National University Hospital
Deokjin-gu, Jeollabuk-do, Korea, Republic of, 561-712
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Dong-A University Medical Center (Dong-A University Hospital)
Busen, Korea, Republic of, 602-715
Keimyung University Dongsan Medical Center (KUDMC)
Daegu, Korea, Republic of, 700-712
Daegu fatima hospital
Daegu, Korea, Republic of, 701-724
Daegu Catholic University Medical Center (DCUMC)
Daegu, Korea, Republic of, 705-718
Ajou University Hospital
Gyeonggi-do, Korea, Republic of, 443-721
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Seoul Medical Center
Seoul, Korea, Republic of, 131-795
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00802854     History of Changes
Other Study ID Numbers: A8851025
First Posted: December 5, 2008    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: July 2017

Keywords provided by Pfizer:
anidulafungin
safety
efficacy

Additional relevant MeSH terms:
Abdominal Abscess
Peritonitis
Candidemia
Candidiasis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Fungemia
Sepsis
Candidiasis, Invasive
Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Abscess
Suppuration