Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)
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| ClinicalTrials.gov Identifier: NCT01840319 |
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Recruitment Status :
Completed
First Posted : April 25, 2013
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
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| Survival Status at Day 30 After the Last Intake |
| 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 |
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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)
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Primary Outcome Measures :
- 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
| 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
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01840319 |
| 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 |