Survival Status at Day 30 After the Last Intake
Conditions
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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* Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline | 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. |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 156 |
| Total | 156 |
Baseline characteristics
| Characteristic | Tigecycline |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 30 days after last dose of Tigecycline (Day 108)
Population: Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tigecycline | Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline | 80.60 percentage of participants |