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

Last updated on November 19, 2019

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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- Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer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 TitleRetrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
Official TitleRetrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Population- Patients which has already been enrolled in the previous study protocol initial WYETH 3074A1-4448 then Pfizer B1811030
ConditionSurvival Status at Day 30 After the Last Intake
InterventionNot Provided
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: May 9, 2014)
156
Original Estimated Enrollment
 (submitted: April 22, 2013)
135
Actual Study Completion DateJuly 2013
Actual Primary Completion DateJuly 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01840319
Other Study ID NumbersNRB1810005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2013

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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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