Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

NCT ID: NCT00683332

Last Updated: 2011-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Three-thousand or 10% of total number of patients given tigecycline will be included in the study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complicated Skin and Skin Structure Infections Complicated Intra-abdominal Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Tigecycline (Tygacil)

Intervention Type DRUG

This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tigecycline (Tygacil)

This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.

Exclusion Criteria

* Previously discontinued Tygacil therapy due to significant safety concern.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Manila, , Philippines

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Philippines

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1811057

Identifier Type: -

Identifier Source: secondary_id

3074A1-102235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vaginal Infection Study
NCT00616330 COMPLETED PHASE3