Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
- Conditions
- CandidemiaOther Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
- Registration Number
- NCT00802854
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Adverse Events (AEs) by Severity 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.
Number of Participants With Clinical Response (CR) 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) 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 Adverse Events (AEs) 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.
Number of Participants With Laboratory Abnormalities 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.
Number of Participants With Mycological Response (MR) 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.
Number of Participants With Overall Response (OR) 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.
Number of Participants With Outcome in Response to Adverse Events (AEs) 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' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved).
Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Medical Center (Dong-A University Hospital)
🇰🇷Busen, Korea, Republic of
Keimyung University Dongsan Medical Center (KUDMC)
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center (DCUMC)
🇰🇷Daegu, Korea, Republic of
Daegu fatima hospital
🇰🇷Daegu, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Deokjin-gu, Jeollabuk-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of