Clinical trial NCT01072539: Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Official title: A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections
Community-Acquired Bacterial Pneumonia
Keywords: infection
Tygacil
PMS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 3172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General Hospitals

Brief summary: The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.

Detailed description: Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.

Eligibility criteria: Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

Adults 18 years of age or older, who have one of the followings:

* Complicated skin and skin structure infections
* Complicated intra-abdominal infections
* Community-acquired bacterial pneumonia

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Patients who have known hypersensitivity to tigecycline
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs
timeFrame: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
measure: Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
timeFrame: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Secondary outcomes:
measure: Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment
timeFrame: At the TOC or EOT assessment
measure: Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site
timeFrame: At the TOC or EOT assessment
measure: Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)
timeFrame: At the TOC or EOT assessment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongnam
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: Incheon
city: Iksan-si
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeollabuk-do
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Dobong-Gu
country: Korea, Republic of
facility: Hanil Medical Center
state: Seoul
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center (Dong-A University Hospital)
city: Cheongju-si
country: Korea, Republic of
facility: Cheongju St. Mary's Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center (KUDMC)
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital (KNUH)
city: Daegu
country: Korea, Republic of
facility: Daegu fatima hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center (DCUMC)
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Kangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine- Wonju Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: