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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline | 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. | 30 days after last dose of Tigecycline (Day 108) |
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Inclusion Criteria:
Exclusion Criteria:
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- Patients which has already been enrolled in the previous study protocol initial WYETH 3074A1-4448 then Pfizer B1811030
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Amiens | France | 80054 | France | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Out of 156 participants who were enrolled in initial study 3074A1-4448 (B1811030) (NCT00799591), 138 participants did not have dates of death, hence, survival data was retrospectively collected for these participants in this study. All data were then combined with the existing survival data for an updated survival analysis.
Participants who completed the initial study 3074A1-4448 (B1811030) (NCT00799591) and whose death were not reported at the end of initial study were eligible to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tigecycline | Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Marseille |
| France |
| 13385 |
| France |
| Pfizer Investigational Site | Marseille | France | 13915 | France |
| Pfizer Investigational Site | Montpellier | France | 34295 | France |
| Pfizer Investigational Site | Paris | France | 75877 | France |
| Pfizer Investigational Site | Strasbourg | France | 67200 | France |
| Pfizer Investigational Site | Argenteuil | 95100 | France |
| Pfizer Investigational Site | Ars-Laquenexy | 57530 | France |
| Pfizer Investigational Site | Besançon | 25030 | France |
| Pfizer Investigational Site | Bordeaux | 33000 | France |
| Pfizer Investigational Site | Bordeaux | 33076 | France |
| Pfizer Investigational Site | Clermont-Ferrand | 63003 | France |
| Pfizer Investigational Site | La Tronche | 38700 | France |
| Pfizer Investigational Site | Le Chesnay | 78157 | France |
| Pfizer Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Nice | 06006 | France |
| Pfizer Investigational Site | Rennes | 35033 | France |
| Pfizer Investigational Site | Rouen | France |
| Pfizer Investigational Site | Saint-Etienne | 42055 | France |
| Pfizer Investigational Site | Toulouse | France |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).
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| ID | Title | Description |
|---|---|---|
| BG000 | Tigecycline | Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline | 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. | Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591). | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days after last dose of Tigecycline (Day 108) |
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Due to retrospective nature of the study, adverse events data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tigecycline | Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline. | 0 | 0 | 0 | 0 |
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As this was an observational study therefore, no randomization and control groups were included. This limitation did not allow the comparison of tigecycline treatment.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |