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

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ClinicalTrials.gov Identifier: NCT01840319
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease
Survival Status at Day 30 After the Last Intake

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study
Study Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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)



Primary Outcome Measures :
  1. Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline [ Time Frame: 30 days after last dose of Tigecycline (Day 108) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840319


Locations
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France
Pfizer Investigational Site
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 Cedex, France, 33076
Pfizer Investigational Site
Bordeaux, France, 33000
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 Cedex 20, France, 13915
Pfizer Investigational Site
Marseille, France, 13385
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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01840319     History of Changes
Other Study ID Numbers: NRB1810005
First Posted: April 25, 2013    Key Record Dates
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014
Last Verified: October 2013