Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01072539
First received: February 17, 2010
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections
Community-Acquired Bacterial Pneumonia
Drug: tigecycline

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment [ Time Frame: At the TOC or EOT assessment ] [ Designated as safety issue: No ]
    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 TOC or EOT Assessment by Infection Site [ Time Frame: At the TOC or EOT assessment ] [ Designated as safety issue: No ]
    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) [ Time Frame: At the TOC or EOT assessment ] [ Designated as safety issue: No ]
    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.


Enrollment: 3172
Study Start Date: May 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who have approved indications of Tygacil

Approved indications of Tygacil

-complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia

Drug: tigecycline
As prescribed by physician in usual clinical practice
Other Name: Tygacil

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

Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General Hospitals
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
  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: NCT01072539

Locations
Korea, Republic of
Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of, 443-380
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongnam, Korea, Republic of, 626-770
Gachon University Gil Hospital
Namdong-gu, Incheon, Korea, Republic of, 405-760
Wonkwang University Hospital
Iksan-si, Jeollabuk-do, Korea, Republic of, 573-250
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Hanil Medical Center
Dobong-Gu, Seoul, Korea, Republic of, 132-033
Kosin University Gospel Hospital
Busan, Korea, Republic of, 602-702
Dong-A University Medical Center (Dong-A University Hospital)
Busan, Korea, Republic of, 602-715
Cheongju St. Mary's Hospital
Cheongju-si, Korea, Republic of, 363-568
Keimyung University Dongsan Medical Center (KUDMC)
Daegu, Korea, Republic of, 700-712
Kyungpook National University Hospital (KNUH)
Daegu, Korea, Republic of, 700-721
Daegu fatima hospital
Daegu, Korea, Republic of, 701-724
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-717
Daegu Catholic University Medical Center (DCUMC)
Daegu, Korea, Republic of, 705-718
Korea University Ansan Hospital
Gyeonggi-do, Korea, Republic of, 425-707
Ajou University Hospital
Gyeonggi-do, Korea, Republic of, 443-721
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Jeju National University Hospital
Jeju, Korea, Republic of, 690-767
Yonsei University Wonju College of Medicine- Wonju Christian Hospital
Kangwon-do, Korea, Republic of, 220-701
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine
Seoul, Korea, Republic of, 120752
Kyunghee University Medical Hospital
Seoul, Korea, Republic of, 130-702
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-814
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Asan Medical Center, University of Ulsan
Seoul, Korea, Republic of, 138-736
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Eulji Medical Center
Seoul, Korea, Republic of, 139-711
Hallym University Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 150-950
Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 150-950
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01072539     History of Changes
Other Study ID Numbers: 3074X1-4527  B1811040 
Study First Received: February 17, 2010
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
infection
Tygacil
PMS

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Intraabdominal Infections
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2016