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

Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Survival Status at Day 30 After the Last Intake

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• France
  • Amiens Cedex 1, France, 80054
    • Pfizer Investigational Site
  • Argenteuil, France, 95100
    • Pfizer Investigational Site
  • Ars Laquenexy, France, 57530
    • Pfizer Investigational Site
  • Besancon cedex, France, 25030
    • Pfizer Investigational Site
  • Bordeaux, France, 33000
    • Pfizer Investigational Site
  • Bordeaux Cedex, France, 33076
    • Pfizer Investigational Site
  • Clermont Ferrand Cedex, France, 63003
    • Pfizer Investigational Site
  • Clermont-Ferrand, France, 63003
    • Pfizer Investigational Site
  • La Tronche, France, 38700
    • Pfizer Investigational Site
  • Le Chesnay cedex, France, 78157
    • Pfizer Investigational Site
  • Le Kremlin Bicetre, France, 94275
    • Pfizer Investigational Site
  • Marseille, France, 13385
    • Pfizer Investigational Site
  • Marseille Cedex 20, France, 13915
    • Pfizer Investigational Site
  • Montpellier, France, 34295
    • Pfizer Investigational Site
  • Nantes Cedex 1, France, 44093
    • Pfizer Investigational Site
  • Nice cedex 1, France, 06006
    • Pfizer Investigational Site
  • Paris Cedex 18, France, 75877
    • Pfizer Investigational Site
  • Rennes Cedex 9, France, 35033
    • Pfizer Investigational Site
  • Rouen Cedex, France
    • Pfizer Investigational Site
  • Saint Etienne Cedex 02, France, 42055
    • Pfizer Investigational Site
  • Strasbourg, France, 67200
    • Pfizer Investigational Site
  • Toulouse, France
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Patients which has already been enrolled in the previous study protocol initial WYETH 3074A1-4448 then Pfizer B1811030

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline	Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.	30 days after last dose of Tigecycline (Day 108)

Collaborators and Investigators

• Sponsor: 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: February 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: NRB1810005