Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

NCT01072539 | Completed Results

• 2 other identifiers: 3074X1-4527B1811040
• Study Type: observational
• Target: 3,172
• Locations: 1 country
• Sites: 36

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.

Conditions

Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections; Community-Acquired Bacterial Pneumonia

Keywords

infection; Tygacil; PMS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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

• Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)

  At the TOC or EOT assessment

Study Arms (1)

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

Interventions

tigecycline DRUG

As prescribed by physician in usual clinical practice

Also known as: Tygacil

Patients who have approved indications of Tygacil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (36)

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Gachon University Gil Hospital

Namdong-gu, Incheon, 405-760, South Korea

Location

Wonkwang University Hospital

Iksan-si, Jeollabuk-do, 573-250, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Hanil Medical Center

Dobong-Gu, Seoul, 132-033, South Korea

Location

Kosin University Gospel Hospital

Busan, 602-702, South Korea

Location

Dong-A University Medical Center (Dong-A University Hospital)

Busan, 602-715, South Korea

Location

Cheongju St. Mary's Hospital

Cheongju-si, 363-568, South Korea

Location

Keimyung University Dongsan Medical Center (KUDMC)

Daegu, 700-712, South Korea

Location

Kyungpook National University Hospital (KNUH)

Daegu, 700-721, South Korea

Location

Daegu fatima hospital

Daegu, 701-724, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

Daegu Catholic University Medical Center (DCUMC)

Daegu, 705-718, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 425-707, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 443-721, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Gachon University Gil Hospital

Incheon, 405-760, South Korea

Location

Jeju National University Hospital

Jeju City, 690-767, South Korea

Location

Yonsei University Wonju College of Medicine- Wonju Christian Hospital

Kangwon-do, 220-701, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine

Seoul, 120752, South Korea

Location

Kyunghee University Medical Hospital

Seoul, 130-702, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, 134-701, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 134-814, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Asan Medical Center, University of Ulsan

Seoul, 138-736, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Eulji Medical Center

Seoul, 139-711, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 150-950, South Korea

Location

Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital

Seoul, 150-950, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Infections

Interventions

Tigecycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 22, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 29, 2023
• Results First Posted: May 30, 2016

Record last verified: 2023-12

Locations

KR (36)