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

Pfizer156 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

156

Conditions

Survival Status at Day 30 After the Last Intake

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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for which mortality status was not known at the closure of this previous study Exclusion Criteria: * Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.

Locations (21)

Pfizer Investigational Site

Amiens, France, France

Pfizer Investigational Site

Marseille, France, France

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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