Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
NCT01840319
Last updated date
ABOUT THIS 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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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- Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer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.
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Survival Status at Day 30 After the Last IntakeRetrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
NCT01840319
- Amiens Cedex 1,
- Argenteuil,
- Ars Laquenexy,
- Besancon cedex,
- Bordeaux Cedex,
- Bordeaux,
- Clermont Ferrand Cedex,
- Clermont-Ferrand,
- La Tronche,
- Le Chesnay cedex,
- Le Kremlin Bicetre,
- Marseille Cedex 20,
- Marseille,
- Montpellier,
- Nantes Cedex 1,
- Nice cedex 1,
- Paris Cedex 18,
- Rennes Cedex 9,
- Rouen Cedex,
- Saint Etienne Cedex 02,
- Strasbourg,
- Toulouse,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 | 156 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2013 | |||