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

Last updated on March 26, 2020

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Study Location
Pfizer Investigational Site
Amiens Cedex 1, , 80054 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Survival Status at Day 30 After the Last Intake
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer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

NCT01840319
Pfizer
Completed
Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)

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Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Survival Status at Day 30 After the Last Intake
Intervention Not Provided
Study Groups/Cohorts 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)
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2014)
156
Original Estimated Enrollment
 (submitted: April 22, 2013)
135
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840319
Other Study ID Numbers NRB1810005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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