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CompletedNCT00802854Updated Nov 21, 2018Results posted

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

An observational study in Candidemia and Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis), sponsored by Pfizer. Completed at 10 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
244
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Candidemia
  • Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)

Keywords

  • anidulafungin
  • safety
  • efficacy
03

In context

Candidemia

73 studies on the registry are indexed under Candidemia; 5 are open to participants now.

This study's enrollment of 244 is close to the median of 246 across 26 observational studies indexed under Candidemia.

Browse Candidemia studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

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.
    • to the active substance, or to any of the .
    • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
244 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  2. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  3. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  4. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  5. 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).

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  6. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  7. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  8. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  9. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

  10. 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.

    Time frame: From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis

07

Results

Posted Nov 30, 2017

Participant flow

Participant flow — Overall Study
MilestoneEraxis
Started244
Completed244
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsEraxis
AEs141
SAEs102
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
ParticipantsEraxis
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)8
PrimaryDuration 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Mean · days
Duration of Adverse Events (AEs)
daysEraxis
Duration of Adverse Events (AEs)4.03 ± 5.81
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Number · events
Number of Adverse Events (AEs) by Severity
eventsEraxis
Mild33
Moderate43
Severe109
PrimaryNumber 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).

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Outcome in Response to Adverse Events (AEs)
ParticipantsEraxis
Yes106
Unknown7
No, resolved28
PrimaryPercentage 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Number · percentage of AEs
Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
percentage of AEsEraxis
Certain1.08
Probable/likely0
Possible5.95
Unlikely92.43
Conditional/unclassified0
Unaccessible/unclassifiable0.54
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Abnormalities
ParticipantsEraxis
Number of Participants With Laboratory Abnormalities35
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Clinical Response (CR)
ParticipantsEraxis
Cure88
Improvement89
Failure19
Unevaluable3
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Mycological Response (MR)
ParticipantsEraxis
Eradication149
Presumed eradication28
Persistence16
Presumed persistence6
Unevaluable0
Superinfection0
PrimaryNumber 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.

Time frame:
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Reported as:
Count of participants · Participants
Number of Participants With Overall Response (OR)
ParticipantsEraxis
Effective173
Ineffective26
Unevaluable0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eraxis—102/244 (41.8%)52/244 (21.3%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventEraxis
SEPSISInfections and infestations45/244
PNEUMONIARespiratory, thoracic and mediastinal disorders8/244
MULTIPLE ORGAN FAILUREGeneral disorders7/244
CARDIAC ARRESTCardiac disorders3/244
GASTRIC CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)3/244
NEOPLASM MALIGNANTNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/244
RESPIRATORY INSUFFICIENCYRespiratory, thoracic and mediastinal disorders3/244
RENAL FAILURE ACUTERenal and urinary disorders3/244
CARDIAC FAILURECardiac disorders2/244
HEPATIC FAILUREHepatobiliary disorders2/244
Most frequent other events
Showing 10 of 42
Most frequent other events
EventEraxis
FEVERGeneral disorders6/244
BILIRUBINAEMIAHepatobiliary disorders6/244
HYPERTENSIONCardiac disorders4/244
CONVULSIONSNervous system disorders3/244
MELAENAGastrointestinal disorders3/244
SGPT INCREASEDHepatobiliary disorders3/244
PHOSPHATASE ALKALINE INCREASEDMetabolism and nutrition disorders3/244
DELIRIUMPsychiatric disorders3/244
MEDICINE INEFFECTIVEGeneral disorders2/244
ADRENAL INSUFFICIENCYEndocrine disorders2/244

Baseline characteristics

Safety analysis set included all participants who received at least 1 dose of Eraxis.

Age, Customized
Age, Customized(Participants)Eraxis
Less than (<) 30 years6
30-39 years19
40-49 years26
50-64 years84
Greater than or equal to (>=) 65 years109
Sex: Female, Male
Sex: Female, Male(Participants)Eraxis
Female107
Male137
08

Study locations

10 sites
  • Chonbuk National University Hospital
    Deokjin-gu, Jeollabuk-do 561-712, Korea, Republic of
  • Dong-A University Hospital
    Busan, 602-715, Korea, Republic of
  • Dong-A University Medical Center (Dong-A University Hospital)
    Busen, 602-715, Korea, Republic of
  • Keimyung University Dongsan Medical Center (KUDMC)
    Daegu, 700-712, Korea, Republic of
  • Daegu fatima hospital
    Daegu, 701-724, Korea, Republic of
  • Daegu Catholic University Medical Center (DCUMC)
    Daegu, 705-718, Korea, Republic of
  • Ajou University Hospital
    Gyeonggi-do, 443-721, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 120-752, Korea, Republic of
  • Seoul Medical Center
    Seoul, 131-795, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00802854
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 5, 2008
Start date
Mar 2, 2012
Primary completion
May 20, 2016
Completion
May 20, 2016
Results posted
Nov 30, 2017
Last update
Nov 21, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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