Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)

NCT ID: NCT01840319

Last Updated: 2014-07-28

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

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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

The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.

Detailed Description

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

Conditions

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

Survival Status at Day 30 After the Last Intake

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

RETROSPECTIVE

Study Groups

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

1

Patients previously included in the initial protocol WYETH 3074A1-4448 / B1811030. (To collect only status survival data 30 days after the last dose of treatment)

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* All patients included in the previous study WYETH 3074A1-4448 then Pfizer B1811030 for which mortality status was not known at the closure of this previous study

Exclusion Criteria

* Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.
Minimum Eligible Age

18 Years

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.

Responsibility Role SPONSOR

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

Amiens, France, France

Site Status

Pfizer Investigational Site

Marseille, France, France

Site Status

Pfizer Investigational Site

Marseille, France, France

Site Status

Pfizer Investigational Site

Montpellier, France, France

Site Status

Pfizer Investigational Site

Paris, France, France

Site Status

Pfizer Investigational Site

Strasbourg, France, France

Site Status

Pfizer Investigational Site

Argenteuil, , France

Site Status

Pfizer Investigational Site

Ars-Laquenexy, , France

Site Status

Pfizer Investigational Site

Besançon, , France

Site Status

Pfizer Investigational Site

Bordeaux, , France

Site Status

Pfizer Investigational Site

Bordeaux, , France

Site Status

Pfizer Investigational Site

Clermont-Ferrand, , France

Site Status

Pfizer Investigational Site

La Tronche, , France

Site Status

Pfizer Investigational Site

Le Chesnay, , France

Site Status

Pfizer Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

Pfizer Investigational Site

Nantes, , France

Site Status

Pfizer Investigational Site

Nice, , France

Site Status

Pfizer Investigational Site

Rennes, , France

Site Status

Pfizer Investigational Site

Rouen, , France

Site Status

Pfizer Investigational Site

Saint-Etienne, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Countries

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

France

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.

NRB1810005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Bosentan in the Treatment of Giant Cell Arteritis
NCT06957002 NOT_YET_RECRUITING PHASE2