Trial record 14 of 27 for:    "Abdominal Abscess"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00802854
First received: December 3, 2008
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Food and Drug Administration regulations.


Condition Intervention Phase
Candidemia
Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Drug: anidulafungin treatment
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint on Final efficacy. - Clinical response - Mycological response - Overall response (consisting of a combination of both clinical and mycological response). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Endpoint on Safety. - Incidence of adverse event. - Others, abnormal finding from laboratory test (if any). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Unexpected adverse event (especially, occurrence of serious adverse events). [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • The circumstantial factor of adverse event appearing under after maintained certain drug. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Factors affecting safety. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
  • Factors affecting efficacy. [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]

Enrollment: 214
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
anidulafungin treatment group
A group of patients diagnosed as Candidemia or other forms of Candida infections (intra-abdominal abscess, and peritonitis) and receive anidulafungin by their physician
Drug: anidulafungin treatment
200mg loading then followed by 100mg daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be enrolled by continuous registration method. It means that the physician should enroll all patients to whom Eraxis IV is administered for the first time after contract is made and agree to participate in this study by signing the 'data privacy statement'.All subjects enrolled should meet the usual prescribing criteria for Eraxis IV as per the local product document and should be entered into the study at the physician's discretion.

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Use in the treatment of the following fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)
  • Evidence of a personally signed and dated informed consent document (data privacy statement) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Use in the treatment of the following fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)
  • Evidence of a personally signed and dated informed consent document (data privacy statement) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802854

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00802854     History of Changes
Other Study ID Numbers: A8851025
Study First Received: December 3, 2008
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
anidulafungin
safety
efficacy

Additional relevant MeSH terms:
Abdominal Abscess
Abscess
Candidiasis
Peritonitis
Candidemia
Suppuration
Infection
Inflammation
Pathologic Processes
Mycoses
Peritoneal Diseases
Digestive System Diseases
Fungemia
Sepsis
Candidiasis, Invasive
Systemic Inflammatory Response Syndrome
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014