Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Complicated Intra-abdominal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072539
• Other study ID #: 3074X1-4527
• Secondary ID: B1811040
• Status: Completed
• Start date: May 2010
• Est. completion date: April 2015

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3172
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Bacterial Pneumonia
• Complicated Intra-abdominal Infections
• Complicated Skin and Skin Structure Infections
• Infections
• Intraabdominal Infections
• Pneumonia, Bacterial

Intervention

Drug:
• tigecycline
As prescribed by physician in usual clinical practice

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Medical Center (Dong-A University Hospital)	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Cheongju St. Mary's Hospital	Cheongju-si
Korea, Republic of	Daegu Catholic University Medical Center (DCUMC)	Daegu
Korea, Republic of	Daegu fatima hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center (KUDMC)	Daegu
Korea, Republic of	Kyungpook National University Hospital (KNUH)	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Hanil Medical Center	Dobong-Gu	Seoul
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Wonkwang University Hospital	Iksan-si	Jeollabuk-do
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Yonsei University Wonju College of Medicine- Wonju Christian Hospital	Kangwon-do
Korea, Republic of	Gachon University Gil Hospital	Namdong-gu	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center, University of Ulsan	Seoul
Korea, Republic of	Eulji Medical Center	Seoul
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyunghee University Medical Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongnam

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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

External Links

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