Clinical trial NCT01840319: Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
Official title: Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival Status at Day 30 After the Last Intake
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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* Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.

Primary outcomes:
measure: Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline
timeFrame: 30 days after last dose of Tigecycline (Day 108)
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens Cedex 1
country: France
facility: Pfizer Investigational Site
city: Argenteuil
country: France
facility: Pfizer Investigational Site
city: Ars Laquenexy
country: France
facility: Pfizer Investigational Site
city: Besancon cedex
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand Cedex
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand
country: France
facility: Pfizer Investigational Site
city: La Tronche
country: France
facility: Pfizer Investigational Site
city: Le Chesnay cedex
country: France
facility: Pfizer Investigational Site
city: Le Kremlin Bicetre
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 20
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 1
country: France
facility: Pfizer Investigational Site
city: Nice cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 18
country: France
facility: Pfizer Investigational Site
city: Rennes Cedex 9
country: France
facility: Pfizer Investigational Site
city: Rouen Cedex
country: France
facility: Pfizer Investigational Site
city: Saint Etienne Cedex 02
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: