Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment

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.

Study Overview

• Status: Completed
• Conditions: Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections; Community-Acquired Bacterial Pneumonia
• Intervention / Treatment: Drug: tigecycline

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.

• Study Type: Observational
• Enrollment (Actual): 3172

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

General Hospitals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Tygacil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs	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.	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.
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (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 .	At the TOC or EOT assessment
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site	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 .	At the TOC or EOT assessment
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)	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.	At the TOC or EOT assessment

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 17, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimated): February 22, 2010

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: infection; Tygacil; PMS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Intraabdominal Infections; Pneumonia, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline
• Other Study ID Numbers: 3074X1-4527; B1811040 (Other Identifier: Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No