Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
- Conditions
- Community-Acquired Bacterial PneumoniaComplicated Skin and Skin Structure InfectionsComplicated Intra-abdominal Infections
- Interventions
- Registration Number
- NCT01072539
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3172
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who have approved indications of Tygacil tigecycline Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics 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. Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (\<65 years or \>=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs 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. All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site At the TOC or EOT assessment Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment At the TOC or EOT assessment Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) At the TOC or EOT assessment Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.
Trial Locations
- Locations (33)
Hanil Medical Center
🇰🇷Dobong-Gu, Seoul, Korea, Republic of
Dong-A University Medical Center (Dong-A University Hospital)
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan-si, Jeollabuk-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Daegu fatima hospital
🇰🇷Daegu, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Cheongju St. Mary's Hospital
🇰🇷Cheongju-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Kyungpook National University Hospital (KNUH)
🇰🇷Daegu, Korea, Republic of
Yonsei University Wonju College of Medicine- Wonju Christian Hospital
🇰🇷Kangwon-do, Korea, Republic of
Keimyung University Dongsan Medical Center (KUDMC)
🇰🇷Daegu, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Kyunghee University Medical Hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Gyeongnam, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center (DCUMC)
🇰🇷Daegu, Korea, Republic of
Asan Medical Center, University of Ulsan
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of